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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

The customer provided the following timeline of events: on (b)(6) 2016, the patient went to the emergency room for pelvic pain from fall.At 12:45pm: cardinal health hcg test produced false negative result.Sample was colorless/clear and showed a specific gravity of 1.002.At 3:13pm: cardinal health hcg test on new sample produced false negative result.No notation of sample color or clarity.A third false negative hcg was obtained on cardinal health hcg test using same sample as one of previous tests.A serum sample was run on the roche cobas with an hcg result of 9946.0 miu/ml.An x-ray was conducted on the patient in the emergency room during visit.Patient determined to be 31 weeks pregnant.Last menstrual period unavailable.

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention and return products.Retention products were tested with 25miu/ml hcg and three high level hcg urine controls.Retention products showed hcg positive results at read time and met qc specifications.No false negative results were obtained.Returned products were tested with returned urine samples and both samples showed negative results.Returned product was also tested with returned serum sample and a positive result was obtained.Customer's observation was verified.The returned samples were sent to a reference lab and it was observed that the hcg levels in the returned urine samples were less than the detectable levels of the device.However, a negative result with the urine sample is the expected outcome.Therefore, no problem was detected.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG CASS. 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6143528
• MDR Text Key: 61396334
• Report Number: 2027969-2016-00700
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Lot Number: HCG6060227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 29 YR