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

Model Number FHC-A102

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Information (3190)

Patient Problem Miscarriage (1962)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting was performed with the customer.Reviewed limitations of test per the pi: this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.False negative results may occur when the levels of hcg are below the sensitivity of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.Reviewed hcg product information notice (pin) with customer which discusses the intended use and limitations of the test.Investigation pending.

Event Description

Conflicting results on the consult diagnostics hcg urine cassette kit.Urine was negative at the 3-minute read time, then a line appeared in the test region at around 5 minutes.Patient interpreted to be positive.No confirmatory testing performed.Unspecified date: positive hcg result 2x on an unspecified at-home pregnancy kit.On (b)(6) 2018: patient presented to the facility to confirm positive hcg results obtained on the at-home pregnancy kit.A new urine sample was collected and tested 1x on the consult diagnostics hcg urine cassette.At 3 minutes there was no line in the test region, however, at around 5 minutes, a positive line appeared in the test region.Result was interpreted as a positive result.No confirmatory testing to be performed.No treatment was provided or withheld based on the interpreted positive hcg result obtained on the consult diagnostics hcg urine cassette kit.The patient is scheduled for an ultrasound on (b)(6) 2018.Complainant confirmed course of action would not have differed if the result was interpreted as negative.After being tested on (b)(6) 2018 and interpreted as positive using the consult diagnostics hcg urine cassette, the patient was referred to the ob/gyn or her doctor.The patient bled later that day.On (b)(6) 2018: patient went to planned parenthood and a new urine sample was tested on an unspecified hcg test.A negative result was obtained.Planned parenthood prescribed an unknown type of antibiotic, as the patient had an unknown type of infection.Based off this negative urine test, planned parenthood determined the patient to be not pregnant.Customer does not believe any confirmatory testing was performed at planned parenthood and is unable to confirm.On (b)(6) 2018: the patient called facility to cancel the scheduled (b)(6) 2018 ultrasound.Customer states the patient may have had a possible miscarriage.

Manufacturer Narrative

Investigation conclusion: retention and returned devices for the reported lot were tested with clinical negative urine samples and cut-off standard.All devices tested with the quality control cut-off standard yielded expected positive results.All devices tested with clinical urine samples yielded expected negative results.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.Retention and returned devices performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.A line in the test region (t) seen after the read time could be indicative of a low hcg level in the sample.If such results are seen, it is recommended that the test be repeated with a new sample 48 hours later.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: CONSULT HCG URINE CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 8201458
• MDR Text Key: 132384622
• Report Number: 2027969-2018-00169
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)190731(10)HCG7080115
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: FHC-A102
• Device Lot Number: HCG7080115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR