MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST STRIP (URINE)

Model Number FHC-101

Device Problem False Negative Result (1225)

Patient Problem Ectopic Pregnancy (1819)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Customer unwilling to return.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.A root cause could not be determined as only limited information was provided.Per the package insert, this test may produce false negative results.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.

Event Description

Customer reports they have experienced several false negative results in the last months when using the hcg one step pregnancy test strip (urine) kit.On (b)(6) 2021, a patient experiencing an ectopic pregnancy was tested and obtained a false negative result.As the false negative result was inconsistent with the clinical picture and ultrasound image, a confirmatory beta hcg was performed.The confirmatory test provided a positive result of 2832 miu/ml.The event led to a delay in the medical procedure.The procedure was a laparoscopic salpingectomy performed urgently on (b)(6) 2021.Failure to identify an ectopic pregnancy due to a false negative hcg result will be considered life-threatening, however, the diagnosis of ectopic pregnancy occurred independently of use of the hcg one step pregnancy strip (urine) kit.The false negative result caused a delay of the surgery.Although there was no negative patient outcome reported, the delay of the procedure is being conservatively considered as a serious injury.

• Brand Name: HCG ONE STEP PREGNANCY TEST STRIP (URINE)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9975 summers ridge road; san diego, CA 92121 ; 8588052506
• MDR Report Key: 11682587
• MDR Text Key: 261745979
• Report Number: 2027969-2021-00031
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2021
• 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 Outcome(s): Other