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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG DIPSTICK URINE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE
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ALERE SAN DIEGO, INC. HENRY SCHEIN HCG DIPSTICK URINE; 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 10/23/2023
Event Type  malfunction  
Manufacturer Narrative
Results pending completion of the investigation.H3 other text : although requested, device return is not anticipated.
 
Event Description
The customer reported a combination of false positive hcg and invalid results with lot 0000677096 and two other lots while using henry schein hcg dipstick urine tests.The patient was sent to the ob/gyn and a false positive result was determined.The customer was unable to clarify which lots experienced false positive or invalid results.Although it was not confirmed, an mdr will conservatively be filed on each lot number.No adverse event reported.See mdr- 2027969-2023-00105 and 2027969-2023-00106 for the two additional mdrs.
 
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 with strong control lines.No false positive results or invalid issues 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 miu/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.- invalid: control line fails to appear.Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure.Review the procedure and repeat the test with a new test strip.If the problem persists, discontinue using the test kit immediately and contact your local distributor.H2 - if follow-up, what type?: updated as investigation was completed.H6 - adverse event problem: updated as investigation was completed.H10 - additional mfg narrative: updated as investigation was completed.
 
Event Description
The customer reported a combination of false positive hcg and invalid results with lot 0000677096 and two other lots while using henry schein hcg dipstick urine tests.The patient was sent to the ob/gyn and a false positive result was determined.The customer was unable to clarify which lots experienced false positive or invalid results.Although it was not confirmed, an mdr will conservatively be filed on each lot number.No adverse event reported.See mdr- 2027969-2023-00105 and 2027969-2023-00106 for the two additional mdrs.
 
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Brand Name
HENRY SCHEIN HCG DIPSTICK URINE
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 Key18132089
MDR Text Key328129382
Report Number2027969-2023-00104
Device Sequence Number1
Product Code JHI
UDI-Device Identifier10304040024093
UDI-Public(01)10304040024093(17)250206(10)0000677096
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 11/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFHC-101
Device Catalogue Number9004072
Device Lot Number0000677096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2023
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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