MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST DEVICE (URINE)(40T/KIT); HCG PREGNANCY TEST

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: return sample was disposed of by the customer and could not be returned for testing.Retention products were tested with hcg quality control cut-off standard (25miu/ml) and high level hcg clinical urine (203.5iu/ml, 215.7iu/ml, 219.4iu/ml).All devices showed positive results at read time.The product passed quality control specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Upon retesting with a new sample from the patient on the same day, the device gave the expected positive result.Case details indicate the patient may have tampered with the initial urine sample.This cannot be ruled out as a possible root cause for the reported issue.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Event or Problem Description
The patient's last menstrual period was (b)(6) 2018.On (b)(6) 2018, the patient arrived at the facility to confirm a pregnancy and start prenatal care.The customer was unable to provide the reason the patient believed she was pregnant.A urine sample was collected and an hcg one step pregnancy test device produced a negative result.As the customer expected a positive result, a repeat test was performed using a clarity hcg test and a negative hcg result was also obtained.Twenty minutes after these two tests, the customer retested the same urine sample using a second hcg one step pregnancy test device and received another negative result.An ultrasound was performed on the patient and the patient was determined to be 18 weeks pregnant.Following the ultrasound, a second urine sample was collected and tested using a third hcg one step pregnancy test device.A positive hcg result was received using the second urine sample.The customer stated that the patient was also being tested for a drug screen as part of their new patient enrollment procedure.Per the customer, the patient may have tampered with the first urine sample due to the urine drug screen.However, the customer cannot confirm whether the patient may be tampered with the sample.Although the sample was requested for investigation, the customer discarded the sample.

• Brand Name: HCG ONE STEP PREGNANCY TEST DEVICE (URINE)(40T/KIT)
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7679923
• Report Number: 2027969-2018-00087
• Device Sequence Number: 13664992
• Product Code: JHI
• UDI-Device Identifier: 10815845020109
• UDI-Public: (01)10815845020109(17)191130(10)HCG7120145
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: FHC-102
• Device Lot Number: HCG7120145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR