MAUDE Adverse Event Report: ALERE SAN DIEGO MEDLINE HCG URINE DIPSTICK; HCG PREGNANCY TEST

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.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.Retain testing and manufacturing record review could not be performed as a lot number could not be obtained.No information regarding technique, storage, or handling could be obtained.A root cause could not be determined due to insufficient information.Complaints are tracked and trended on a monthly basis.Per the package insert, false negative results may occur when the levels of hcg are below the sensitivity level of the test.Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.

Event Description

Three hcg tests read negative with the same lot number.When the patients performed drug store hcg tests the same day, they received positive results.No adverse event was reported and no other information is available although requested.

• Brand Name: MEDLINE HCG URINE DIPSTICK
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego, ca
• Manufacturer Contact: monika burrell ; 9975 summers ridge road; san diego, ca ; 8052506
• MDR Report Key: 9827513
• MDR Text Key: 188827068
• Report Number: 2027969-2020-00008
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1