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

Model Number FHC-A202-OBW515

Device Problem False Negative Result (1225)

Patient Problem Abdominal Pain (1685)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

Customer reported a potential false negative urine hcg result with hcg combo device sp brand rapid test vs serum result.Customer stated that a patient came into the er with abdominal pain.The initial urine test with the hcg combo device sp brand rapid test was graded negative by the er tech.The urine was retested and came back as a very weak positive result.A serum sample was sent to the lab for a quantitative test which resulted in a positive at >400,000miu/ml.The doctor also confirmed a positive with an ultrasound.The caller did not know how far along the patient was in her pregnancy.No information was available such as last menstrual period, medications or health issues for the patient.

Manufacturer Narrative

Investigation pending.

• Brand Name: HCG COMBO DEVICE SO 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: 3850864
• MDR Text Key: 4408194
• Report Number: 2027969-2014-00110
• 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: Other
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• 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: HCG2120254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• 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