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

Model Number FHC-101

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of false negative urine hcg results received on consult hcg dipstick test 5000 25t.Patient's lmp: (b)(6) 2016.Patient exhibiting early signs of pregnancy.On (b)(6) 2016, initial hcg test on consult hcg dipstick received negative results.No follow-up testing performed.Serum quant test was not performed.No procedure/treatment performed based on perceived discrepant results.It was stated the current status of patient is a normal pregnancy.Confirmatory method of pregnancy not reported.No reported adverse patient sequela.

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 controls and 3 high-level hcg urine controls.All results were hcg-positive at the read time and met the qc specification.False negative results were not 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.No corrective action is required at this time.

• 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: 6181848
• MDR Text Key: 62924630
• Report Number: 2027969-2016-00705
• 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,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Device Lot Number: HCG6040183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• 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: 27 YR