MAUDE Adverse Event Report: CARDINAL HEALTH RAPID TEST HCG DIP; HCG PREGNANCY TEST

Model Number FHC-101-OBW01

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

A (b)(6) female patient visited the clinic to confirm positive results from home pregnancy testing.An hcg urine test was performed using cardinal health hcg dipstick rapid test and a negative result was observed.The patient's last menstrual period was on (b)(6) 2016.Patient was requested to return to clinic on (b)(6) 2016 to repeat rapid test and may be requested to do a quantitative serum test.No further information was provided.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG DIP
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5934910
• MDR Text Key: 54586492
• Report Number: 2027969-2016-00614
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• 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: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101-OBW01
• Device Lot Number: HCG4120205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/07/2016
• 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
• Patient Age: 34 YR