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

Model Number FHC-101-OBC517

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Patient b which is referenced is reported under separate medwatch manufacturer report # 2027969-2015-01022.Investigation/conclusion: the customer's observation was not replicated in-house with retention devices.The retention devices were tested with 3 high level of hcg urine controls (201.4 iu/ml, 204.2 iu/ml and 212.2 iu/ml); all results were hcg positive at read time and no false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined without patient specimen in-house analysis and specific information provided.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

Customer reported potential false negative hcg results using the consult hcg dipstick test 5000 pregnancy tests on 2 different patients.Patient a presented to office on (b)(6) 2015 with a positive home test.The first morning urine was tested and the urine was clear with normal smell.The patient was not taking any medications and had no health issues.The test was clearly negative, with strong control line.A repeat of same sample was still negative.Ultrasound follow-up showed pregnancy of 9 weeks.The result on the consult test was not used.Patient received routine pregnancy care.Same day blood quantitative hcg result was 210,000 miu/ml by quest laboratory.There was no samples or product available for further investigation.Product: there was no abnormalities with product received, storage, procedure and the external qc record is complete.There was no adverse patient sequela.There was no additional information provided.Patient b submitted on separate medwatch form.

• Brand Name: CONSULT HCG DIPSTICK TEST 5000
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5319097
• MDR Text Key: 34147976
• Report Number: 2027969-2015-01021
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2015

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: HCG5050048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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