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

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of investigation.

Event Description

It was reported by the distributor that a customer, with additional testing, detected levels outside of the "claimed range" (thought to be detecting false positive results).No confirmatory information provided.There were no injuries or adverse event.

Manufacturer Narrative

Additional information: d3: email: (b)(6).Phone number: (b)(6).D4: udi number added, (b)(4).D10: device available for eval, changed to "no".G1/g2: first name: (b)(6).Last name: (b)(6).Phone number: ((b)(6).H3: device evaluated by manufacturer, answer changed to "no".Investigation conclusion: an investigation was performed on retention products for the reported lot number.Retention products were tested with clinical negative urine and serum samples.All test devices produced expected negative results at their respective sample read times.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.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.Information in regards to sample collection, sample matrix, confirmatory testing, device handling, device storage, testing technique, and patient factors were unable to be obtained.Therefore, a root cause could not be determined.This test is designed to detect hcg concentrations of 10 miu/ml or greater in serum and 20 miu/ml or greater in urine.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: MEDLINE HCG COMBO CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9205108
• MDR Text Key: 189225225
• Report Number: 2027969-2019-00577
• 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: 01/08/2020

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: 02/28/2021
• Device Model Number: FHC-A202
• Device Lot Number: HCG9030061
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1