MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URIN/SRM COMBO 5002 25; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: retention products were tested with hcg quality control cut-off standard (20miu/ml) and mid-level hcg clinical urine (100miu/ml).Returned products were tested with hcg quality control cut-off standard (25miu/ml) and high level hcg clinical urine (212.6iu/ml, 215.2iu/ml, 221.9iu/ml).All devices showed positive results at read time and met quality control specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The reported complaint could not be replicated with retention product.Product performed as expected.This issue will continue to be monitored through incoming complaints.Case details do not indicate if the urine sample was a first morning catch.Per the package insert, very dilute urine may not contain representative levels of hcg.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The patient presented to the facility to confirm a pregnancy after missing her menstrual period and obtaining a positive result on an unspecified home pregnancy test.A urine sample was collected and a consult hcg urine/serum combo test produced a negative hcg result.The facility ordered a serum quantitative test on the same day and received a positive hcg result of154 miu/ml.Troubleshooting was conducted with the customer.The customer was determined to be not testing controls, not using a timer, and did not allow the urine sample to acclimate to room temperature before testing.The customer was advised to test controls and use a timer to ensure the test is read at the designated read time.Very diluted urine specimens (as indicated by low specific gravity) may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is suspected, a first-morning urine specimen should be collected 48 hours later and tested.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002 25
• 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: 7930755
• MDR Text Key: 124971553
• Report Number: 2027969-2018-00126
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202786
• UDI-Public: (01)20612479202786(17)200131(10)HCG8020018
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: FHC-A202
• Device Lot Number: HCG8020018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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