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

Model Number FHC-102

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention products for the reported lot number.Retention products were tested with clinical negative urine samples.Results were read at 3 and 4 minutes and all test devices produced expected negative 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 abnormalities.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.Review of the information provided did not identify any evidence of misuse.There is no indication that the customer deviated from the package insert.Per the package insert: very low levels of hcg (less than 50 miu/ml) are present in urine specimens shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.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

This event occurred in (b)(6).A patient had a faint line on an hcg one step pregnancy test device (urine) and it was interpreted as a positive result at the medical center on (b)(6) 2019.Then on (b)(6) 2019 at a women's clinic, the patient had a negative result on the same product with a different lot number.On the same day, an hcg beta < 2 iu/l result occurred at a lab (unknown testing method).No treatment was given due to discrepant result.

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9319102
• MDR Text Key: 189209146
• Report Number: 2027969-2019-00600
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FHC-102
• Device Lot Number: HCG9010123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR