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

Model Number FHC-102-OBW515

Device Problem False Negative Result (1225)

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

A customer reported potential false negative urine hcg results twice with cardinal health hcg rapid test vs.Quantitative blood test.A (b)(6) female visited the ed on (b)(6) 2016 for vomiting and abdominal pain; discharged within 3 hours.Testing was performed on an afternoon urine sample from this patient with a negative result.A second test was run on the patient's urine sample using a test from the same lot but different box with negative results.A quantitative blood test was run on the same day with a result of 549miu/ml.No patient history was available.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention and return devices.Retention and return devices were tested with 25 miu/ml hcg cutoff urine control and 100 miu/ml urine control; 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.The root cause could not be determined based on the information provided by the customer and without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5760152
• MDR Text Key: 49242372
• Report Number: 2027969-2016-00477
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2017
• Device Model Number: FHC-102-OBW515
• Device Lot Number: HCG5100083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• 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