MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG 10/20 PREGNANCY TEST DEVICE(SERUM/URINE)

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

Unspecified date: patient presented to the facility in an ambulance after a high speed mva roll over.The patient required trama series x-ray's and ct's.The patient was tested 2x on the hcg 10/20 pregnancy test device and both results were negative.Ct was performed based on the false negative results.Confirmatory blood work was also performed, and the result was 110 miu/ml.Result of confirmatory blood work was not obtained until after the ct was performed.The patient was admitted to the facility for observation overnight and discharged the next day.Customer states the patient is still considered to be pregnant.No adverse outcomes reported.Although further information was requested, no further information was provided.

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention product from the reported lot number.Retention devices were tested with qc cutoff standard (20 miu/ml) and middle positive standard (100 miu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.The complaint history for this lot was reviewed and no indications of a systemic issue were identified.A root cause could not be determined from the available information, as retention product performed as expected during in-house testing.Please note, 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.This test provides only 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

New information received reported that the patient also tested herself on an at-home pregnancy test x2 and received positive x2 results.It is unknown what test brand was used.The patient was ok and gave birth to the baby.

• Brand Name: HCG 10/20 PREGNANCY TEST DEVICE(SERUM/URINE)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 8359752
• MDR Text Key: 136802408
• Report Number: 2027969-2019-00026
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: FHC-A202
• Device Lot Number: HCG8050140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 02/22/2019; 04/09/2019
• Supplement Dates FDA Received: 02/27/2019; 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other