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 Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with 20 miu/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

Customer reported receiving false negative hcg results from a couple of emergency room patients using cardinal health hcg combo rapid test.Customer questioning why a negative hcg result would eventually become positive after read time.Customer did not provide patient specific information.Specific date of occurrence not provided.Customer claiming a beta quant was run.Customer randomly gave results of <2.0 miu/ml, 40 miu/ml, 15 miu/ml (although according to the customer, these results may not be specific to the patients in this case).No reported adverse patient sequela.Although requested, 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: 6129637
• MDR Text Key: 60967566
• Report Number: 2027969-2016-00695
• 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

• 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: HCG6040095
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/28/2016
• 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