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

Model Number FHC-102

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Devices not returned.Product expended by the customer.Investigation conclusion: an investigation was performed on retained devices from the reported lot number.Retained devices were tested with qc cut-off hcg standard (25 miu/ml) and results were read at 3 minutes.All devices produced expected positive results at the read time.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.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.Batch record review found no relevant non-conformances; the lot met all final release specifications.It was reported that the patient's test was read a second time after 40-60 minutes had elapsed and the result was interpreted to be positive.As stated in the package insert, read the results at 3-4 minutes.Do not interpret results after the appropriate read time.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by physician after all clinical and laboratory findings have been evaluated.

Event Description

(b)(6) 2019: patient presented to the facility for a 6-week post partum standard of care visit.A urine specimen was collected in a clean, dry cup at 11:30 am and tested on the medline hcg urine cassette.After 4 minutes, a negative result was obtained.After approximately 40-60 minutes, a positive result was observed on the same cassette.No additional information was able to be provided to determine whether the customer expected the result to be negative or positive.No confirmatory testing was performed.Although further information was requested, no further information was provided by the customer.

Manufacturer Narrative

Device code 4101 added.Investigation conclusion: an investigation was performed on retention and returned devices from the reported lot number.Retention and returned devices were tested with qc cut-off hcg standard (25 miu/ml) and results were read at 3 minutes.All devices produced expected positive results at the read time.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.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.Batch record review found no relevant non-conformances; the lot met all final release specifications.It was reported that the patient's test was read a second time after 40-60 minutes had elapsed and the result was interpreted to be positive.Per the package insert, read the results at 3-4 minutes.Do not interpret results after the appropriate read time.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by physician after all clinical and laboratory findings have been evaluated.

• Brand Name: MEDLINE HCG URINE CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 9365626
• MDR Text Key: 188848394
• Report Number: 2027969-2019-00591
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30888277191871
• UDI-Public: (01)30888277191871(17)210331(10)HCG904013
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• 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: 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: 03/31/2021
• Device Model Number: FHC-102
• Device Lot Number: HCG9040133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRENATAL VITAMS (UNSPECIFIED DOSE)
• Patient Age: 20 YR
• Patient Weight: 101