MAUDE Adverse Event Report: ALERE SAN DIEGO, INC MEDLINE HCG COMBO CASSETTE; PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention products for the reported lot number.Retention products were tested with clinical negative serum sample and low concentration serum standards (2 miu/ml hcg).Results were read at 5 and 6 minutes and all test devices produced expected negative results.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any abnormalities.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.Review of the information provided did not identify any evidence of misuse.There is no indication that the customer deviated from the package insert.The reported hcg concentration for the serum specimen was 5.1 miu/ml.This test is designed to detect hcg concentrations of 10 miu/ml or greater in serum and 20 miu/ml or greater in urine.Due to the high sensitivity of this test, the presence of hcg below these concentrations may produce positive results.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy should only be made by a physician after all clinical and laboratory findings have been evaluated.Product discarded by customer.

Event Description

(b)(6) 2019: patient presented to facility for a menstrual migraine and calculus of the bile duct.Patient was scheduled for an emergent gallbladder surgery.Two separate serum specimens were collected and tested on the medline hcg combo cassette which provided two false positive results.Two separate urine specimens were also collected and tested on the medline hcg combo cassette which provided two negative results.A confirmatory quantitative hcg was performed and provided a result of 5.1 miu/ml.Customer states the surgery does not appear to be delayed based on the false positive results.No adverse patient outcomes were reported.

• Brand Name: MEDLINE HCG COMBO CASSETTE
• Type of Device: 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: 9227656
• MDR Text Key: 189221003
• Report Number: 2027969-2019-00583
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30884389191884
• UDI-Public: (01)30884389191884(17)201231(10)HCG9010053
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FHC-A202
• Device Lot Number: HCG9010053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• 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 Age: 46 YR