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

Model Number FHC-A102

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/28/2018

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.Note: (b)(4).However, this report is conservatively being filed with inclusion of a product problem (malfunction) report type.Please refer to mdr# 2027969-2018-00151 for negative hcg results on consult hcg urine cassette lot number hcg8060056.

Event Description

The patient's last menstrual period was (b)(6) 2018.On (b)(6) 2018, the patient presented to the facility for a previously scheduled iud placement.A urine sample was collected and a consult hcg urine cassette (lot number unavailable) produced a negative hcg result.As the patient was taking an oral birth control method and the negative hcg result was not questioned, no confirmatory testing was conducted and the facility performed the iud placement.The iud placement was verified by ultrasound.(the level of hcg on (b)(6) 2018 cannot be determined from the information provided from the customer.It is unclear whether the hcg concentration was above the limit of detection of the test.) approximately two weeks later, the patient began to experience symptoms of a pregnancy.The patient performed three home pregnancy tests (brand unspecified) and received a positive result each time.On (b)(6) 2018, the patient returned to the facility due to the pregnancy symptoms.A urine sample was collected and a consult hcg urine cassette (lot number hcg8060056) produced a negative hcg result.A repeat test was also performed and another consult hcg urine cassette (lot number hcg8060056) also produced a negative hcg result.(please refer to mdr# 2027969-2018-00151 for negative hcg results on consult hcg urine cassette lot number hcg8060056).As a positive result was expected, a serum hcg quantitative test was ordered.On (b)(6) 2018, the facility received the result of the serum hcg quantitative test of 51,933 miu/ml.On (b)(6) 2018, the patient returned to the facility for iud removal.However, the removal was unsuccessful.Per the customer, chart notes indicate that the iud is lodged in the anterior wall of the fundus.A follow-up appointment was scheduled for (b)(6) 2018 but the appointment was cancelled by the patient and the patient was transferred to another provider.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: 8026394
• MDR Text Key: 125756289
• Report Number: 2027969-2018-00150
• Device Sequence Number: 1
• Product Code: JHI
• 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: Other
• Type of Report: Initial
• Report Date: 10/31/2018

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-A102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/31/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 29 YR