MAUDE Adverse Event Report: ALERE SAN DIEGO CARDINAL HEALTH RAPID TEST HCG COMBO; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

It was reported that on (b)(6) 2020, a cardinal hcg combo rapid test had a confirmed false positive.Although requested, no further information nor data has been provided.There was no adverse event, no injury nor death.

Manufacturer Narrative

D: udi number (b)(4).D9: no.H3: not returned to manufacturer.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded the expected negative results.Retained devices were also tested with hcg-negative clinical serum samples.The results were read at 5 and 6 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 retention product.Complaints are tracked and trended on a monthly basis.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: CARDINAL HEALTH RAPID TEST HCG COMBO
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 11013711
• MDR Text Key: 239810680
• Report Number: 2027969-2020-00089
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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: 02/28/2022
• Device Model Number: FHC-A202
• Device Lot Number: HCG0032078
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1