MAUDE Adverse Event Report: CONSULT HCG URINE CASSETTE 5001- 25T; HCG PREGNANCY TEST

Model Number FHC-A102-OBC554

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml hcg urine control and 3 high level of hcg urine controls (201.8 iu/ml, 203.4 iu/ml and 205.2 iu/ml); all results were hcg positive at read time.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 and insufficient information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Report of fn urine hcg on (b)(6) 2015.(b)(6) 2015 qualitative serum = positive.Patient reported "spotting." (b)(6) 2015 ultrasound showed no visible intrauterine gestational sac.(b)(6) 2015 beta quant was 5 miu/ml.(b)(6) 2015 beta quant was <1 miu/ml.Customer cannot state if pregnancy was terminated or if patient miscarried.Date unknown.Patient was administered depo-provera because the rapid assay resulted negative at the designated read time of 3-5 minutes; however, the operator noticed a faint test line after 10 minutes (and ran it twice).Thus, next day bloodwork was done and the beta quant was positive (awaiting concentration).The serum was tested twice - on (b)(6) 2015 blood was drawn and sent out to labcorp and a qualitative assay was run and the result was positive (brand unknown).A quant was done (b)(6) 2015 and was 5 miu/ml.A second quant was run on (b)(6) 2015 and resulted as <1 miu/ml (instrument unknown).No specific patient information provided.No additional details reported.

• Brand Name: CONSULT HCG URINE CASSETTE 5001- 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5291216
• MDR Text Key: 33346421
• Report Number: 2027969-2015-01005
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• 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: 11/20/2015

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-A102-OBC554
• Device Lot Number: HCG5010147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/11/2015
• 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