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

Model Number FHC-A202-OBW515

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

A potential false negative urine hcg result was reported with cardinal health rapid test hcg combo test vs.A positive quantitative hcg result.It was reported that a (b)(6) female came into the office with a 'threatened abortion', spotting and was tested with the cardinal health rapid test hcg combo test yielding a negative result.The patient's last menstrual period was (b)(6) 2016.The patient's diagnosis and current condition were reported to be: threatened abortion.The patient was still spotting but in no pain.She had performed 2 home pregnancy tests on (b)(6) 2016 and both were reported to be positive.A quantitative hcg test was performed with a result of 131miu/ml.No further information was available.

• 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: 5828419
• MDR Text Key: 51516660
• Report Number: 2027969-2016-00535
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: FHC-A202-OBW515
• Device Lot Number: HCG5070112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2016
• 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: 30 YR