MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG DIPSTICK TEST 5000 25T; HCG PREGNANCY TEST

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem Miscarriage (1962)

Event Date 04/25/2018

Event Type  Death  

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 patient's last menstrual period was (b)(6) 2018.On (b)(6) 2018, the patient arrived at facility for a scheduled sonohysterogram (sono hsg).A urine sample was collected and produced a negative result using a consult hcg dipstick test.The sono hsg procedure was performed following the negative hcg result.The same day, a serum sample was collected and produced a positive quantitative hcg result of 241.1 mlu/ml on a roche diagnostics instrument.The patient's progesterone was also reported as 0.85.During a follow-up conducted on (b)(6) 2018, the customer stated the patient was currently undergoing a miscarriage.The miscarriage was referred to as "spontaneous" and the customer stated is it unknown whether the pregnancy was initially viable.However, no additional information was provided.The customer reported the event on behalf of a sister facility.

• Brand Name: CONSULT HCG DIPSTICK TEST 5000 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: 7543585
• MDR Text Key: 109223019
• Report Number: 2027969-2018-00066
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• 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): Death
• Patient Age: 32 YR
• Patient Weight: 68