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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER SURE-VUE HCG STAT SERUM/URINE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE
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ALERE SAN DIEGO, INC. FISHER SURE-VUE HCG STAT SERUM/URINE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE Back to Search Results
Model Number FHC-A202
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Manufacturer Narrative
Results pending completion of the investigation.
 
Event Description
The customer reported receiving a false positive hcg result while using the fisher sure-vue hcg stat serum/urine device.The customer indicated two fresh blood draws were collected from the patient.One sample was hemolyzed and the other was non-hemolyzed.The customer reported receiving a false positive result, however it is unclear which sample type yielded this result.Confirmatory testing was performed using a roche cobas 6000 which yielded a negative hcg result.No adverse event reported.
 
Manufacturer Narrative
D9 - device available for evaluation: changed from "yes" to "no".Investigation conclusion: an investigation was performed on retention product from the reported lot number.Retention devices were tested with clinical negative serum samples.Results were read at 5 and 6 minutes and all devices yielded expected 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 abnormalities 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.Case details indicate blood/serum samples were collected where one sample was hemolyzed and the other was not.It was unable to be determined which sample yielded the false result.Per the package insert, non-hemolyzed specimens should be used when possible.Additionally, please ensure only serum or urine are tested on this device.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 50miu/ml) are present in urine and serum 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 serum or urine specimen collected 48 hours later.- a number of conditions other than pregnancy, including trophoblastic disease and certain nontrophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.- as with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.- 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.
 
Event Description
The customer reported receiving a false positive hcg result while using the fisher sure-vue hcg stat serum/urine device.The customer indicated two fresh blood draws were collected from the patient.One sample was hemolyzed and the other was non-hemolyzed.The customer reported receiving a false positive result, however it is unclear which sample type yielded this result.Confirmatory testing was performed using a roche cobas 6000 which yielded a negative hcg result.No adverse event reported.
 
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Brand Name
FISHER SURE-VUE HCG STAT SERUM/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 Key19008649
MDR Text Key339126783
Report Number2027969-2024-00039
Device Sequence Number1
Product Code JHI
UDI-Device Identifier00613647000533
UDI-Public(01)00613647000533(17)250404(10)0000702336
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062361
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 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFHC-A202
Device Catalogue Number23900531
Device Lot Number0000702336
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/24/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/06/2023
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 Age41 YR
Patient SexFemale
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