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

Model Number FHC-A202

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer's observation was not replicated in-house with retention products.Retention products were tested with 20miu/ml hcg and 3 high levels of hcg urine controls.Retention products showed hcg positive results at read time and met qc specifications.No false negative results 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 received of two false negative hcg results for emergency department patients using cardinal health rapid test hcg combo 30t.Customer questioning why a negative result would eventually become positive after read time.Customer did not provide patient specific information.Customer reported they used 3 drops, read time 3 mins received negative results (then read again greater than 4mins, maybe as long as 30mins later, and result was positive).No reported adverse patient sequela.No additional information provided.

• 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: 6142491
• MDR Text Key: 61402453
• Report Number: 2027969-2016-00699
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Lot Number: HCG6060066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2016
• 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