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 No Code Available (3191)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: retention products were tested with urine hcg qc standard at and above 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.This product provides only a qualitative, preliminary analytical result.A secondary analytical method must be used to obtain a confirmed result.Because return product or specimen were not available, further investigation was not pursued.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

On (b)(6) 2018, the patient arrived at the facility for a scheduled sonohysterogram (sono hsg).A urine sample was collected and a consult hcg dipstick test produced a negative result.Based on the negative hcg result, the sono hsg was performed.On (b)(6) 2018, a serum quantitative hcg test was conducted on a roche diagnostics instrument and produced a result of 10,662.0 mlu/ml.The patient's progesterone was reported as 20.46.As of (b)(6) 2018, the customer reported that there have not been any pregnancy difficulties or complications following the sono hsg.

• 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: 7543596
• MDR Text Key: 109224568
• Report Number: 2027969-2018-00064
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202751
• UDI-Public: (01)20612479202751(17)190531(10)HCG7050178
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: FHC-101
• Device Lot Number: HCG7050178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/24/2018
• 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: 36 YR
• Patient Weight: 60