MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG URINE DIPSTICK; PREGNANCY TEST

Model Number FHC-101

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation.

Event Description

Unspecified date: patient presented to facility for an unspecified reason.Patient was tested five times on the medline hcg dipstick kit and two false positive results were obtained.No adverse outcomes were reported.Although further information was requested, no further information was able to be obtained from the customer; customer unresponsive.

Manufacturer Narrative

Update to d9: device available for evaluation=no update to h3: devices not returned 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.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.No details regarding technique, storage, or handling could be obtained.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: MEDLINE HCG URINE DIPSTICK
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 11595547
• MDR Text Key: 250026600
• Report Number: 2027969-2021-00026
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30884389191877
• UDI-Public: (01)30884389191877(17)220331(10)HCG0032128
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: FHC-101
• Device Lot Number: HCG0032128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1