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

Model Number FHC-A102

Device Problem False Negative Result (1225)

Patient Problem No Code Available (3191)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: retention products were tested with an urine hcg qc standard at the cut-off.All of the tests produced positive results at the read time and met qc release specifications.No false negative results were observed.The product performed as expected.Manufacturing batch record review did not uncover any abnormalities.If the concentration of sample is lower than cut-off, a negative result may be observed.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The patient's last menstrual period was approximately (b)(6) 2018.On (b)(6) 2018, the patient arrived at the facility for a nexplanon implant.A urine sample was collected and produced a negative result using the consult hcg urine cassette.The nexplanon was subsequently implanted based on the negative result.On (b)(6) 2018, the patient phoned the facility to report nausea and vomiting.The patient informed the facility that a home pregnancy test was performed and produced a positive result.The customer was unable to provide the date of the positive home pregnancy test result.On (b)(6) 2018, the patient retuned to the facility.A urine sample was collected and produced a positive result using the consult hcg urine cassette.The nexplanon was subsequently removed.On (b)(6) 2018, a third consult hcg urine cassette test was performed and also produced a positive result.No confirmatory testing was performed and the customer was unable to provide an estimated date of conception.Although no confirmatory testing was conducted and the estimated date of conception is not available, this event is conservatively being reported due to the customer's allegation the patient was pregnant at the time of the initial test on (b)(6) 2018.

• 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: 7539159
• MDR Text Key: 109099496
• Report Number: 2027969-2018-00058
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)190831(10)HCG7090064
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: FHC-A102
• Device Lot Number: HCG7090064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 96