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 Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg urine control and 3 high level of hcg urine controls (205.2 iu/ml, 208.6 iu/ml and 216.8 iu/ml), 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 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.

Event Description

Report received of false negative hcg results for one patient.On (b)(6) 2015 positive hcg result for patient at (b)(6) in (b)(6).On (b)(6) 2015 false negative hcg result for patient, lot # hcg4070214.Patient started on birth control, received shot in (b)(6) office.On (b)(6) 2015 false negative hcg result for patient, lot # hcg5030059.Patient received next birth control shot in (b)(6) office.On (b)(6) 2015 patient went to emergency room and was informed she was about 20 wks pregnant, per ultrasound results.Reason for visit to emergency room was not stated.On (b)(6) 2015 positive hcg result for patient in (b)(6) office.Although requested several times, no additional information was received.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: 5320205
• MDR Text Key: 34168019
• Report Number: 2027969-2015-01024
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2015

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: HCG5030059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/22/2015
• 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