MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URINE CASSETTE 5001 25T; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention products of the reported lot.Retention products were tested with qc cutoff hcg urine standards and clinically negative urine samples.All devices tested with qc cutoff standards showed positive results at read time meeting qc specifications.Additionally, devices tested with clinically negative urine samples showed expected negative results at read time.None of the devices showed any evidence change in results or any other readability issue during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Based on the complaint information, the result changed from negative to positive after an hour and also that the second positive line did not come up at 3 minutes but showed up later.According to the pi, it is recommended to read the results at 3 minutes only.If a faint line appears in the test region after the read time, it is recommended that the test be repeated with a new sample in 48-72 hours or that an alternate confirmation method is used.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The distributor reported the events on behalf of the customer.The customer reported receiving negative hcg results using the consult hcg urine cassette on three patients.However, after an hour, a line is observed in the test region of the consult hcg urine cassette and the report is amended to reflect a positive hcg result.Although requested, no additional information was provided.

Manufacturer Narrative

Additional information was received from the customer and event or problem was updated to reflect current information.

Event Description

The distributor reported the events on behalf of the customer.The customer reported receiving negative hcg results using the consult hcg urine cassette on three patients.However, after an hour, a line is observed in the test region of the consult hcg urine cassette and the report is amended to reflect a positive hcg result.In an update received, the customer specified that beta serum concentrations of 80 miuml to 120 miu/ml were obtained.The customer also stated the events may have been due to operator error.Although requested, no additional information was provided.

• Brand Name: CONSULT HCG URINE CASSETTE 5001 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 7136402
• MDR Text Key: 96006929
• Report Number: 2027969-2017-00191
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)190430(10)HCG7050076
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: FHC-A102
• Device Lot Number: HCG7050076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/15/2018
• 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