MAUDE Adverse Event Report: ALERE SAN DIEGO HCG ONE STEP PREGNANCY TEST STRIP (URINE); HCG PREGNANCY TEST

Model Number FHC-101

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

Patient Problem No Information (3190)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

The customer reported that an hcg test had discrepant results.Initially, the test had no visual result at an unknown read time, then showed a negative result at an unknown later read time.Ten minutes later, the strip showed a positive result.No confirmatory results received and no adverse event was reported.

Manufacturer Narrative

Additional information/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.The retained devices were also tested with qc cut-off standards (25miu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.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.Additional information regarding testing technique, kit storage conditions or patient details could not be obtained.A root cause could not be determined from the available information, as the reported issue was not replicated during testing of retained devices.However, it is important that the results are read at the appropriate read time.Per the package insert, read the result at 3-4 minutes.Do not interpret results after the appropriate read time.A sample hcg concentration below the cut-off level of this test might result in a weak line appearing in the test region (t) after an extended period of time.A line in the test region (t) seen after the read time could be indicative of a low hcg level in the sample.If such results are seen, it is recommended that the test be repeated with a new sample in 48-72 hours or that an alternate confirmation method is used.

Manufacturer Narrative

B1 product problem, delete.H1 malfunction, delete.H1 was initially submitted as a malfunction.The selection will remain unchanged due to the field requiring a selection.Upon review of the investigation as part of the file closure, it was determined that the customer received an invalid result.The case was incorrectly assessed as a false result and no product malfunction that can lead to serious injury occurred.

• Brand Name: HCG ONE STEP PREGNANCY TEST STRIP (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9370979
• MDR Text Key: 188833053
• Report Number: 2027969-2019-00605
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2020

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: 02/29/2020
• Device Model Number: FHC-101
• Device Lot Number: HCG8020055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 02/11/2020; 03/10/2020
• Supplement Dates FDA Received: 02/11/2020; 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1