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 Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report from customer alleging receipt of one false negative hcg result for one patient.Customer states the test line was negative at 3-4 minutes.Physician placed an iud in the patient, came back and looked at the test and it was faintly positive.They ran 2 additional tests, (11:50am and 12:00pm) using the consult diagnostics hcg dipstick test and they were positive immediately.Physician removed the iud.Patient's lmp (b)(6) 2016.No reported adverse patient sequela.

Manufacturer Narrative

Investigation / conclusion: 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; 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.Root cause could not be determined due to insufficiency information provided by 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.

Manufacturer Narrative

Corrections: report source corrected to remove company representative and include consumer.

• Brand Name: CONSULT HCG DIPSTICK TEST 5000 - 25T
• Type of Device: HCG PREGNANCY TEST
• MDR Report Key: 5475489
• MDR Text Key: 39753636
• Report Number: 2027969-2016-00129
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101-OBC517
• Device Lot Number: HCG5030254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR