MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST STRIP (URINE); HCG PREGNANCY TEST

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem No Code Available (3191)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.As the customer did not provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer reported receiving four negative hcg results using the hcg one step pregnancy test strip on (b)(6) 2018, (b)(6) 2018, (b)(6) 2018, and (b)(6) 2018 on one patient.Each time, the patient collected the sample at home and brought in to the facility for testing two to three hours later.The patient was waking cerelle and clopidogrel.Per the customer, the patient was pregnant during all four tests and did not become aware of her pregnancy until she was five months pregnant.The patient is due to deliver the baby in (b)(6).The customer also stated that the product may have been exposed to very low temperature as it was left in the car during winter time.

Event Description

The patient continued to take the contraceptive mini pill cerelle following the false negative hcg results.However, no adverse patient outcome was reported by the customer.

Manufacturer Narrative

A valid lot number was not provided, therefore an investigation was performed on all unexpired lots of the reported product.Devices from these lots were tested with qc cutoff standard and high-hcg clinical urine samples.Results were read at 3 minutes and all devices yielded expected positive results.Manufacturing batch record review for these lots did not uncover any abnormalities and found that the lots met quality control specifications.A root cause could not be determined from the available information as all lots performed as expected.Case details indicate that the devices may have been exposed to very low temperatures.Please note, per the package insert, the devices should be stored as packaged in the sealed pouch at 2-30°c and should never be frozen.

Manufacturer Narrative

The event problem and evaluation codes were inadvertently not provided in follow-up #1.The event problem and evaluation codes are provided in this follow-up.

• Brand Name: HCG ONE STEP PREGNANCY TEST STRIP (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7961396
• MDR Text Key: 123562216
• Report Number: 2027969-2018-00134
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 11/20/2018; 01/16/2019
• Supplement Dates FDA Received: 12/10/2018; 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other