MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG COMBO CASSETTE; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

It was reported that on an unspecified date, the patient presented for pre-operation and was tested on the medline hcg combo cassette.The patient received a negative result and had a surgery performed.It is unknown what procedure was performed.The patient was tested again after the surgery and received a positive result.It was interpreted that the patient was pregnant.No further information was available.Technical services reached out to the customer to conduct troubleshooting.The customer was unresponsive.

Manufacturer Narrative

Correction: b5 updated with new event information that the medline hcg combo cassette showed a negative result at the 5 minute window, but showed positive when read after 30 minutes.The patient was not pregnant and was taking fertility medication.Correction: mdr was incorrectly submitted.This is not a reportable event.Based on the information provided by the customer in the case, the customer was not reading the result during the appropriate read window as described in the package insert.Per device labeling: serum/urine combo: "read the result at 3-4 minutes when testing a urine specimen, or at 5-6 minutes when testing a serum specimen.Do not interpret results after the appropriate read time." the results were correctly interpreted as negative within the read window and this is consistent with the patient's pregnancy status of not pregnant.

Event Description

New information received reported that the medline hcg combo cassette showed a negative result at the 5 minute window, but showed positive when read after 30 minutes.The patient was not pregnant and was taking fertility medication.

Manufacturer Narrative

Retention products for the reported lot number were tested with clinical negative urine and serum samples.Results were read at 3 and 4 minutes for urine samples and at 5 and 6 minutes for serum samples.All test devices produced expected negative results.Additionally, returned product was investigated and tested with cut-off hcg serum standard (10 miu/ml).The test device produced an expected positive result at the 5-minute read time.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Although results should not be interpreted after the read time, four returned, used devices were visually examined.Faint lines were observed in the test and control regions on all devices.Due to the age of the devices, it could not be determined which test device gave the observed negative result or a positive result or if the test lines had appeared within the read time of the test.Case details indicate the positive results were observed after 30 minutes.Per the product insert, results should not be interpreted after the appropriate read time.

Manufacturer Narrative

Event description changed.Patient was tested once and not twice.The patient was ok and not determined to be pregnant.Patient was on fertility medication.Report type- changed to product problem.There was no adverse event.Patient code- changed to 2692.

Event Description

New information reported that the patient was tested once on the medline hcg combo cassette pregnancy test and showed a negative result when read at 5 minutes.The patient underwent the surgery.The same pregnancy test result then showed a positive result 30 minutes after.The patient went to the obstetrician and was deternined to not be pregnant.The patient's status was ok.

• Brand Name: MEDLINE HCG COMBO CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8712124
• MDR Text Key: 148427890
• Report Number: 2027969-2019-00114
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30884389191884
• UDI-Public: (01)30884389191884(17)200731(10)HCG8080082
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: FHC-A202
• Device Lot Number: HCG8080082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/24/2019; 07/22/2019; 08/30/2019
• Supplement Dates FDA Received: 07/16/2019; 07/23/2019; 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1