MAUDE Adverse Event Report: BIOLYTICAL LABORATORIES INC INSTI HIV-1/HIV-2 ANTIBODY TEST; INSTI HIV TEST, PRODUCT CODE: QSU, PRODUCT CODE: QSU

Model Number 90-1019

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

Event description: the customer reported one false negative result with insti hiv-1/hiv-2 antibody test lot no.1019230073.The patient was regularly visiting the clinic for routine sti testing.On (b)(6) 2023, the patient visited the clinic with the intention of starting prep dose.As part of the screening process before prescribing prep, the patient was tested on insti hiv test with a negative result with fingerstick blood sample.(no photos are available for negative test results).No other available medical history of the patient, except that the patient was known to be reactive for rpr.The patient's blood was collected on the same day and sent to the local health department for stis for hiv, gonorrhea, hepatitis b and c testing with western blot.The results from western blot were received as positive for hiv a week later (b)(6) 2023).This was communicated to the patient and referred them to a doctor to arrange hiv genotype testing prior to starting anti-retroviral (art).Biolytical received the complaint of false negative with insti test on (b)(6) 2023.A second insti hiv test was not conducted due to insufficient patient sample available at the clinic.Biolytical investigation summary: on september 28, 2023, the customer support team initiated an investigation of kit lot 1019230073 involved in the reported complaint by carrying out a review of the production batch records and performing testing using retention kits related to insti kit lot 1019230073.Production batch record review: all the manufacturing and quality control documentation were reviewed for kit lot 1019230073.All test components passed essential qc inspections and relevant production records did not show any non-conformities.Retention kit testing: testing was carried out on qc retention kit lot 1019230073, all testing results were as expected.There were no previous performance-related customer complaints reported for the identified insti hiv kit lot 1019230073.Retention testing results for all retained components were as expected, and the issue reported by the customer could not be replicated.Returned test kits are requested and pending confirmation from the customer.Capa consideration: capa is not warranted at this time as there is no trend of false negative results observed.During biolytical internal investigation, all results were as expected; root cause is undetermined.As there is no malfunction or adverse effect associated with this complaint, capa is not required at this time.Conclusion: based on the internal investigation, all relevant production records did not show any non-conformities and there was no previous performance-related customer complaint reported for the identified insti hiv kit lot 1019230073, its match lot (mu23010), and the corresponding critical components (bmu or color developer).Trend analysis was also conducted for this specific match lot (mu23010) and the overall insti hiv 1/2 antibody test kit in relation to false negative issues and there were no reportable trends observed for both.Therefore, the root cause for this complaint is undetermined.It is important to note that the insti hiv 1/2 antibody test is intended for use as an aid-in-diagnosis kit and not a confirmatory test.In cases where a user may be at risk of exposure and may be experiencing a positive test result, it is recommended to do a confirmatory test for determination of the patient disease conditions as stated in the package insert.There was no potential for harm or serious injury to the patients.Biolytical will be continuously monitoring this kit lot's performance through post-market surveillance activity.A follow up report will be submitted with investigation results from the testing using returned kits once available.

Event Description

The customer reported one false negative result with insti hiv-1/hiv-2 antibody test lot no.1019230073.The patient was regularly visiting the clinic for routine sti testing.On (b)(6) 2023, the patient visited the clinic with the intention of starting prep dose.As part of the screening process before prescribing prep, the patient was tested on insti hiv test with a negative result with fingerstick blood sample.(no photos are available for negative test results).No other available medical history of the patient, except that the patient was known to be reactive for rpr.The patient's blood was collected on the same day and sent to the local health department for stis for hiv, gonorrhea, hepatitis b and c testing with western blot.The results from western blot were received as positive for hiv a week later ((b)(6) 2023).This was communicated to the patient and referred them to a doctor to arrange hiv genotype testing prior to starting anti-retroviral (art).Biolytical received the complaint of false negative with insti test on (b)(6) 2023.A second insti hiv test was not conducted due to insufficient patient sample available at the clinic.

Manufacturer Narrative

Summary of biolytical returned test kit investigation report: an initial report was submitted to the fda on 18 october 2023 (mdr#3003871407-2023-00002), regarding one false negative result with insti hiv-1/hiv-2 antibody test lot no 1019230073.Event description: a patient reported a false negative result with an insti hiv-1/hiv-2 antibody test (lot no.1019230073) during a routine sti screening on september 18, 2023, when they visited a clinic for prep.The patient's blood was later tested using western blot, which showed a positive hiv result on (b)(6) 2023.Biolytical received the complaint of the false negative on (b)(6) 2023.A second insti hiv test was not conducted due to insufficient patient sample.Biolytical would like to submit this follow-up report with the testing results of the returned kits that were investigated internally.Returned kit testing: biolytical requested the customer to return a few test kits to conduct internal investigation and had received a total of 10 insti hiv-1/hiv-2 antibody test kits (lot no.1019230073) on (b)(6) 2023.A total of 10 tests were performed with insti controls 90-1031 (n=1) and hiv-1 low positive control (n=7) to investigate the performance of the returned kits.Testing results were all as expected and no non-conformities were observed.The false negative complaint reported by the customer for kit lot 1019230073 could not be replicated.

Event Description

An initial report was submitted to the fda on 18 october 2023 (mdr#3003871407-2023-00002), regarding one false negative result with insti hiv-1/hiv-2 antibody test lot no 1019230073.A patient reported a false negative result with an insti hiv-1/hiv-2 antibody test (lot no.1019230073) during a routine sti screening on (b)(6) 2023, when they visited a clinic for prep.The patient's blood was later tested using western blot, which showed a positive hiv result on (b)(6) 2023.Biolytical received the complaint of the false negative on (b)(6) 2023.A second insti hiv test was not conducted due to insufficient patient sample.Biolytical would like to submit this follow-up report with the testing results of the returned kits that were investigated internally.

• Brand Name: INSTI HIV-1/HIV-2 ANTIBODY TEST
• Type of Device: INSTI HIV TEST, PRODUCT CODE: QSU, PRODUCT CODE: QSU
• Manufacturer (Section G): BIOLYTICAL LABORATORIES INC; biolytical laboratories inc; 13251 delf pl, unit 406; richmond, british columbia V6V2A 2; CA V6V2A2
• Manufacturer Contact: 13251 delf pl, unit 406; richmond, british columbia V6V2A-2
• MDR Report Key: 18373436
• MDR Text Key: 331205187
• Report Number: 3003871407-2023-00002
• Device Sequence Number: 1
• Product Code: QSU
• UDI-Device Identifier: 00686597010198
• UDI-Public: 00686597010198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP090032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: 90-1019
• Device Catalogue Number: 90-1019
• Device Lot Number: 1019230073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose