MAUDE Adverse Event Report: ICON 25 HCG (COMBO CASSETTE); HCG PREGNANCY TEST

Model Number FHC-202

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The patient was previously confirmed to be pregnant by her gynecologist.The confirmation method and gestational period are not available.On (b)(6) 2017 at 2:00am, the patient arrived at the emergency room for a possible miscarriage due to bleeding.The patient's urine sample was tested using the icon 25 hcg combo cassette and produced a positive hcg result.The patient's serum sample was quantitated using the beckman access 2 and produced a negative hcg result.A new serum sample was collected from the patient and tested on the icon 25 hcg combo cassette.The serum produced a negative hcg result.Although requested, no additional information is available.The customer is unable to clarify the complaint and this report is being conservatively filed.

Manufacturer Narrative

Investigation conclusion: the customer's results were not replicated in-house with retention devices of the reported lot.Retention devices were tested with hcg-positive serum and urine samples at the qc cutoff (25 miu/ml).All of the results were positive at the read time.In addition, retention devices tested with hcg-negative serum and urine samples produced negative results at the read time.All results met the qc release specification.False positive and false negative results were not observed during the investigation.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Correction: (b)(4).

• Brand Name: ICON 25 HCG (COMBO CASSETTE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6397174
• MDR Text Key: 69747132
• Report Number: 2027969-2017-00042
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

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-202
• Device Lot Number: HCG5070223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• 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