MAUDE Adverse Event Report: ALERE SAN DIEGO CARDINAL HEALTH RAPID TEST HCG COMBO 30T; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem Dyspnea (1816)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation completion.

Event Description

It was reported that a (b)(6) female patient presented to the emergency department with a complaint of shortness of breath.The patient's serum sample was tested with a confirmed false positive result on the hcg cassette.On the same day a serum quant was drawn with a result of 5 miu/ml.No treatment, procedure or medication was withheld or provided based on the false positive result.Troubleshooting occurred discussing possible causes such as technique, storage, handling, patient factors, testing procedures and sample appearance with no deviations noted.

Manufacturer Narrative

Additional information: d3: email: (b)(6).Phone number: (b)(6).G1/g2: first name: (b)(6) last name: (b)(6) phone number: (b)(6).Investigation conclusion: retained and returned devices were tested with hcg-negative clinical serum samples and low-hcg standards (2 miu/ml).Results were read at 5 and 6 minutes and all devices yielded expected negative results.No false positive results were observed.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 abnormalities 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.The patient serum sample was tested with retained and returned devices from the complaint lot.Results were read at 5 and 6 minutes and the results were inconsistent.Forty percent of the results were positive, while the rest were negative.Quantitative hcg analysis of the sample was performed.The mean of the results for the serum sample was 5.1 miu/ml.This is below the threshold of 10 miu/ml for this device and sample type.However, when testing samples with hcg-concentrations near cut-off, some positive results may occur.Please note, 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.Complaints are tracked and trended on a monthly basis.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 8890979
• MDR Text Key: 154426754
• Report Number: 2027969-2019-00203
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)200831(10)HCG8090044
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: FHC-A202
• Device Catalogue Number: B1077-23
• Device Lot Number: HCG8090044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR