MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT HCG URINE CASSETTE 5001; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of investigation.

Event Description

It was reported that on an unspecified date (between (b)(6) 2019 to (b)(6) 2019) a confirmed false positive result occurred on the consult diagnostics hcg cassette.Confirmatory testing provided a negative result (confirmatory test method and exact result unable to be provided).No treatment was provided or delayed based on the false positive results.No adverse patient outcome reported.

Manufacturer Narrative

Update to d4: udi number corrected.Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded the expected negative results.No false positive results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of either retention or returned product.Per the package insert, 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 5001
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9182906
• MDR Text Key: 189706411
• Report Number: 2027969-2019-00571
• Device Sequence Number: 1
• Product Code: JHI
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: FHC-A102
• Device Lot Number: HCG9040122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1