MAUDE Adverse Event Report: ALERE SAN DIEGO ALERE HCG CASSETTE; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device eval by manufacturer: yes.Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.Batch record review found no relevant non-conformances; the lot met all final release specifications.An investigation was performed on retention and returned products for the reported lot number.Retention devices were tested with clinical negative urine samples and results were read at 3 minutes.All test devices produced expected negative results at the read time.Returned devices were tested with the returned patient urine sample.The urine sample did appear to have white precipitates, which were allowed to settle prior to testing.Results were read at 3 minutes and all devices tested produced negative results.The patient urine sample was also sent out for quantitative analysis and the mean concentration of hcg found in the sample was 2.6 miu/ml.This is below the cut-off value of the device, therefore, the product performed as expected.Unable to replicate the reported issue during-house testing.Per the package insert, urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.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.

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

It was reported that a (b)(6) old patient visited the clinic and an hcg cassette test was administered.A faint positive result occurred.Retest was administered 2 times with a negative result.Confirmatory testing will not be conducted.The patient was not provided or withheld treatment nor were there changes in medication due to the hcg results to the customer's knowledge.No adverse patient outcome.Troubleshooting occurred with a discussion about the false positive event and possible causes such as technique, storage, handling, and specimen factors per package insert (pi)- no deviations noted.

• Brand Name: ALERE HCG CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• Manufacturer Contact: m burrell ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9143344
• MDR Text Key: 170793501
• Report Number: 2027969-2019-00557
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)210228(10)HCG9030081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: FHC-A102
• Device Lot Number: HCG9030081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR