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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: retention products were tested with hcg quality control cut-off standard (25 miu/ml) and high level hcg clinical urine (212.6 iu/ml, 215.2 iu/ml, 203.5 iu/ml).All devices showed positive results at read time and met quality control release specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Case details do not indicate if the urine sample was a first morning catch.Per the package insert, very dilute urine may not contain representative levels of hcg.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.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The patient's last menstrual period was 2-3 weeks prior to (b)(6) 2018.On (b)(6) 2018, a urine sample was collected and a hcg one step pregnancy test device produced a negative hcg result (urinalysis: glu -ve, ket 15, sg 1.020, blo large, pro trace, nit -ve, leu -ve).A beta hcg quantitative blood test was performed the same day and produced a result of 127 miu/ml with a progesterone of 9 (no units provided).The pregnancy was determined to be non-viable.However, the customer also stated that the patient was on a medication that may have been potentially harmful to a viable pregnancy.On (b)(6) 2018, a repeat beta hcg quantitative blood test was performed and produced a result of 95 miu/ml.On (b)(6), 2018, a third beta hcg quantitative blood test was performed and produced a result of 91 miu/ml.The patient outcome was a miscarriage and the patient was later discharged.

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 7858099
• MDR Text Key: 120109342
• Report Number: 2027969-2018-00118
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2018

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: 03/31/2020
• Device Model Number: FHC-102
• Device Lot Number: HCG8030072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR