MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG COMBO DEVICE SP BRAND RAPID TEST; HCG PREGNANCY TEST

Model Number FHC-A202-OBW515

Device Problem False Negative Result (1225)

Patient Problems Fall (1848); Pregnancy (3193)

Event Date 09/28/2014

Event Type  malfunction  

Event Description

Report of false negative urine pregnancy result with hcg combo device sp brand rapid test vs.Quantitative test.Pregnancy confirmed with bloodwork.(b)(6) old female went to er due to falling down flight of stairs; urine collected 6:00p.M., (b)(6) 2014 and tested with hcg combo device sp brand rapid test shortly thereafter with pouch opened at the time of testing.Nurse who performed the test stated that the procedure was followed, but not timer was used.Read time about 5 minutes.Unable to remember if any issues with sample, such as cloudy, etc.Internal control line visible.Kits stored at room temperature.External controls most likely performed at their central suppley beta/blood results and specific gravity unstable.Cat scan was performed on the patient's abdomen and showed a fetus of approx 8 weeks.No adverse event reported.

Manufacturer Narrative

Investigation pending.

• Brand Name: HCG COMBO DEVICE SP BRAND RAPID TEST
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4216954
• MDR Text Key: 5072436
• Report Number: 2027969-2014-00971
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/08/2014

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 Model Number: FHC-A202-OBW515
• Device Lot Number: HCG4040097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 10/24/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR