MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG COMBO CASSETTE (20/10MIU/ML); PREGNANCY TEST

Model Number 92215

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Devices not returned.Product discarded/expended by customer.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical serum samples.The results were read at 5 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.Case details indicate that the concentration of hcg present in the sample was 8 miu/ml.When testing samples near the threshold of 10 miu/ml some positive results may occur.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.

Event Description

(b)(6) 2019: a (b)(6) female patient visited the facility due to pelvic pain.The patient's serum specimen was collected at 9:32 am and tested on the alere hcg combo cassette.A positive result was obtained at the 5 minute read time.No treatment was provided based on false positive result.The same serum specimen was retested on the beckman access 2 and a confirmatory hcg quant of 7 miu/ml was obtained.(b)(6) 2019: an additional confirmatory quant test was performed on the beckman access 2 and a result of 6 miu/ml was obtained.Although further information was requested, no further information was provided.No adverse patient outcomes were reported.Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi)-no deviations noted.

Manufacturer Narrative

This mdr is a duplicate to mdr submission 2027969-2019-00593.Please disregard this mdr.

• Brand Name: ALERE HCG COMBO CASSETTE (20/10MIU/ML)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 9387355
• MDR Text Key: 188851359
• Report Number: 2027969-2019-00607
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Public: (01)2088538002026817)210228(10)HCG9030087
• 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: 11/27/2019

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: 92215
• Device Catalogue Number: B1077-23
• Device Lot Number: HCG9030087
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR