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 02/09/2021

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.Product testing and manufacturing record review could not be performed as a lot number could not be obtained and product could not be returned.A root cause could not be determined from the available information.However, case details indicate that the result was read at 5-10 minutes, and a timer was not used.Per the directions for use, read the result at 3-4 minutes.Do not interpret results after the appropriate read time.A timer is required.Complaints are tracked and trended on a monthly basis.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

(b)(6) 2021: patient presented to facility after obtaining a positive result on a home pregnancy test (exact brand/specificity not provided).Urine specimen was tested on the hcg one step pregnancy test strip (urine) kit and a negative result was obtained.Due to the negative result, the patient was incorrectly discharged from the hospital.(b)(6) 2021: the patient suffered a ruptured fallopian tube at home and urgent surgical intervention was carried out.Patient had an ectopic pregnancy rupture with intra-abdominal bleeding.The procedure performed was urgent abdominal surgery with unilateral salpingectomy.Confirmatory beta hcg test provided a positive result of 7200 miu/ml.Customer requested they not be contacted further regarding this event.No further information able to be provided.

• 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: 11700565
• MDR Text Key: 262866797
• Report Number: 2027969-2021-00033
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 04/13/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 25 YR