MAUDE Adverse Event Report: CONSULT HCG DIPSTICK TEST 5000 - 25T; HCG PREGNANCY TEST

Model Number FHC-101-OBC517

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products of the reported lot.Retention devices were tested in-house with 25 miu/ml hcg urine cutoff control and 3 high-level hcg urine controls.All results were hcg-positive at the read time and met the qc specification.No false negative results were observed during in-house investigation.A review of manufacturing batch records did not uncover any abnormalities.A root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.

Event Description

Report received of false negative 2 x on consult hcg dipstick test 5000 - 25t.Customer called in stating that with one patient they had observed 2 false negatives at different stages in the pregnancy, dates not provided.The third time they observed a positive value and patient was at (b)(6) along.Patient delivered baby in (b)(6) 2016.Specific patient information not provided.No reported adverse patient sequela.

• Brand Name: CONSULT HCG DIPSTICK TEST 5000 - 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6126019
• MDR Text Key: 60906376
• Report Number: 2027969-2016-00690
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• 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: 10/27/2016

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-101-OBC517
• Device Lot Number: HCG4100176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/23/2016
• 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