MAUDE Adverse Event Report: CARDINAL HEALTH RAPID TEST HCG COMBO 30T; HCG PREGNANCY TEST

Model Number FHC-A202-OBW515

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pendng.

Event Description

Caller reported false negative urine hcg result with cardinal health rapid test hcg combo vs.Ct scan and serum test confirming pregnancy.On (b)(6) 2016 a (b)(6) female presented to the er with left lower quadrant pain lasting once hour.The patient's last menstrual period was (b)(6) 2016.A urine sample was tested with cardinal health rapid test hcg combo test and gave a negative result.The patient went for a ct scan which demonstrated a 'fetus'.The same urine sample was taken to the lab for testing and tested negative with cardinal health rapid test hcg combo kit.A blood sample was taken in the er and tested positive with a serum test and also gave a quantitative result of 11,583 miu/ml.Patient was discharged from the er on (b)(6) 2016.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5689106
• MDR Text Key: 46222625
• Report Number: 2027969-2016-00407
• 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: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: FHC-A202-OBW515
• Device Lot Number: HCG5110120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Date Manufacturer Received: 05/04/2016
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: GABAPENTIN