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

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation.

Event Description

Unspecified date: false negative result on the medline hcg urine dipstick test kit.Prior to visiting the physician's office, the patient had several positive home pregnancy tests (brand/sensitivity unspecified).Pregnancy was confirmed with a beta hcg test.Exact beta hcg result not available.No adverse outcomes were reported.

Manufacturer Narrative

Update to d9: devices were not returned by the customer.Evaluation of returned devices could not be performed.Investigation conclusion: retained devices from the reported lot number were tested with qc cut-off standards (25 miu/ml) and high-hcg clinical urine samples (212.0-215.6 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative 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, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.

• 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: 11008513
• MDR Text Key: 228490350
• Report Number: 2027969-2020-00082
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30884389191877
• UDI-Public: (01)30884389191877(17)211130(10)HCG9122040
• 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: 02/01/2021

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: 11/30/2021
• Device Model Number: FHC-101
• Device Lot Number: HCG9122040
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1