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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG URINE DIPSTICK 25T; VISUAL, PREGNANCY HCG, PRESCRIPTION USE
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ALERE SAN DIEGO, INC. MEDLINE HCG URINE DIPSTICK 25T; VISUAL, PREGNANCY HCG, PRESCRIPTION USE Back to Search Results
Model Number FHC-101
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2023
Event Type  malfunction  
Event Description
The customer reported multiple patients received false positive hcg results using the medline hcg urine dipstick tests.The customer was unable to provide details regarding the number of patients, patient information or testing technique.However, the customer reported testing with the devices with controls yielded passing results.No further information was provided.No injury or harm was reported.
 
Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded valid negative results.No false positive results were observed during in-house testing.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 relevant non-conformances and found that the lot met quality control specifications.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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Per the package insert: - very low levels of hcg (less than 50 mlu/ml) are present in urine specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.- a number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.- 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.
 
Manufacturer Narrative
Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded valid negative results.No false positive results were observed during in-house testing.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 relevant non-conformances and found that the lot met quality control specifications.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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention or returned product.Complaints are tracked and trended on a monthly basis.Per the package insert: very low levels of hcg (less than 50 mlu/ml) are present in urine specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.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.H3 - device evaluated by mfg?: updated to "yes." h6-adverse event problem: updated to include completion of investigation and return device testing.
 
Event Description
The customer reported multiple patients received false positive hcg results using the medline hcg urine dipstick tests.The customer was unable to provide details regarding the number of patients, patient information or testing technique.However, the customer reported testing with the devices with controls yielded passing results.No further information was provided.No injury or harm was reported.
 
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Brand Name
MEDLINE HCG URINE DIPSTICK 25T
Type of Device
VISUAL, PREGNANCY HCG, PRESCRIPTION USE
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
9942 mesa rim rd
san diego CA 92121
Manufacturer Contact
monika burrell
9942 mesa rim rd
san diego, CA 92121
8588052506
MDR Report Key17761184
MDR Text Key323583029
Report Number2027969-2023-00086
Device Sequence Number1
Product Code JHI
UDI-Device Identifier30884389191877
UDI-Public(01)30884389191877(17)240906(10)0000621065
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFHC-101
Device Catalogue NumberMPH11025HCG
Device Lot Number0000621065  
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received11/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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