MAUDE Adverse Event Report: CONSULT HCG URINE CASSETTE; HCG PREGNANCY TEST

Model Number FHC-102

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation/conclusion: customer's observation was not replicated in-house with retention and return devices.Retention and return devices were tested with 20 miu/ml hcg cutoff urine control and returned product was also tested with 100 miu/ml hcg urine control, all results were hcg positive at read time and met quality control specification.There were no false negative results obtained.The manufacturing batch records for the lot were reviewed and the lot met release specifications.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 and no corrective action is required.

Event Description

A (b)(6) old patient obtained a negative result on the consult hcg urine cassette, which was confirmed positive by serum test with a result of 31 miu/ml (the date of testing is unknown).The patient was tested due to a missed period.The last menstrual period was on (b)(6) 2016.The patient's urine sample was collected at 12:00 pm.The caller (who was not the tester) did not know if the sample was clear or cloudy or whether the lab allows a cloudy sample to settle prior to testing.A urine analysis was not performed.The sample was not available, however, unused cassettes were returned.

• Brand Name: CONSULT HCG URINE CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5769572
• MDR Text Key: 48817191
• Report Number: 2027969-2016-00490
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Catalogue Number: 4584655014/5001
• Device Lot Number: HCG5070173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR