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

Model Number FHC-102-OBW515

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention product.Retention products were tested with 25 miu/ml hcg cutoff urine control and 3 high level hcg urine controls (205.3 iu/ml, 210.7 iu/ml and 216.8 iu/ml), all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined based on the information provided by customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

A potential false negative urine hcg result with cardinal health rapid test hcg cassette vs.Positive result with blood test.A (b)(6) year old female patient had a negative urine hcg result; the patient's blood test result was positive (no numeric value was provided).The date of the patient's last menstrual period was (b)(6) 2016.No further patient information was available.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG CASS. 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5787605
• MDR Text Key: 49382126
• Report Number: 2027969-2016-00510
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• 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-102-OBW515
• Device Lot Number: HCG5100083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• 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: 39 YR