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

Model Number FHC-A202-OBW515

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion customer's observation was not replicated in-house with retention product (lot: hcg5110118).Retention products were tested with hcg cutoff urine control and 3 high level of hcg urine controls, 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

Report of false negative hcg results on cardinal health rapid test hcg combo 30t urine cassette.On (b)(6) 2016, a (b)(6) female presented to the emergency department with abdominal pain.Patient was tested for pregnancy with cardinal health urine cassette, lot hcg5090061, result was negative.On (b)(6) 2016, patient returned to the emergency department with abdominal pain.Patient was tested for pregnancy, customer states the lot was one of two possible lots: hcg5110118 or hcg5110121, result was negative.On (b)(6) 2016 patient returned to the emergency department with abdominal pain, back pain, and was tested for pregnancy, lot hcg5110118, result was positive.An ultrasound dated the fetus at (b)(6).Patient delivered on (b)(6) 2016.Patient was unaware that she was pregnant.Lmp not provided.No reported adverse patient sequela.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5918537
• MDR Text Key: 53671183
• Report Number: 2027969-2016-00599
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2016

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-A202-OBW515
• Device Lot Number: HCG 5110121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 08/31/2016
• 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: 20 YR