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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S CHAGAS REAGENT KIT; TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN
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ABBOTT GMBH ALINITY S CHAGAS REAGENT KIT; TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN Back to Search Results
Catalog Number 06P08-45
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2023
Event Type  malfunction  
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06p08-45 that has a similar product distributed in the us, list number 06p08-50 an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported on (b)(6), 2023, a chagas release control result shifted downward and was out-of-range with results of 1.13 and 1.16 s/co (control range: 1.42-7.27 s/co).The customer immediate sent a request for service after obtaining these results that did not pass.The field service representative (fsr) arrive onsite to troubleshoot the issue.After performing the necessary troubleshooting tasks and ran precision testing, the instrument and assay passed.The customer did not provide any specific patient information regarding this issue, however the customer stated that about 2 months ago a donor sample previously generated a negative chagas result, and when retested on another instrument obtained a positive result.When the fsr reviewed both instrument logs, the fsr was unable to find the results that were processed in either instrument.There were no results that repeated on both analyzers, (b)(6) and as1417 with different results.The customer could not provide a specific sample id for the donor sample that the customer had mentioned.There was no impact to patient management reported.
 
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06p08-45 that has a similar product distributed in the us, list number 06p08-50 an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.D4 - lot # initial: unknown; updated to reagent lot 50395be00.
 
Event Description
The customer reported on december 7, 2023, a chagas release control result shifted downward and was out-of-range with results of 1.13 and 1.16 s/co (control range: 1.42-7.27 s/co).The customer immediate sent a request for service after obtaining these results that did not pass.The field service representative (fsr) arrive onsite to troubleshoot the issue.After performing the necessary troubleshooting tasks and ran precision testing, the instrument and assay passed.The customer did not provide any specific patient information regarding this issue, however the customer stated that about 2 months ago a donor sample previously generated a negative chagas result, and when retested on another instrument obtained a positive result.When the fsr reviewed both instrument logs, the fsr was unable to find the results that were processed in either instrument.There were no results that repeated on both analyzers, as1188 and as1417 with different results.The customer could not provide a specific sample id for the donor sample that the customer had mentioned.There was no impact to patient management reported.
 
Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing of a retained reagent kit lot 50395be00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.No increase in complaint activity was identified.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.Clinical sensitivity testing was completed using panels which mimic patient samples using an in-house retained kit of the complaint lot 50395be00.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or product deficiency of the alinity s chagas reagent kit lot 50395be00 was identified.
 
Event Description
The customer reported on (b)(6) 2023, a chagas release control result shifted downward and was out-of-range with results of 1.13 and 1.16 s/co (control range: 1.42-7.27 s/co).The customer immediate sent a request for service after obtaining these results that did not pass.The field service representative (fsr) arrive onsite to troubleshoot the issue.After performing the necessary troubleshooting tasks and ran precision testing, the instrument and assay passed.The customer did not provide any specific patient information regarding this issue, however the customer stated that about 2 months ago a donor sample previously generated a negative chagas result, and when retested on another instrument obtained a positive result.When the fsr reviewed both instrument logs, the fsr was unable to find the results that were processed in either instrument.There were no results that repeated on both analyzers, (b)(6) with different results.The customer could not provide a specific sample id for the donor sample that the customer had mentioned.There was no impact to patient management reported.
 
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Brand Name
ALINITY S CHAGAS REAGENT KIT
Type of Device
TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM   65205
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18626436
MDR Text Key334494679
Report Number3002809144-2024-00026
Device Sequence Number1
Product Code QHM
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/06/2024
Device Catalogue Number06P08-45
Device Lot Number50395BE00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2024
Supplement Dates Manufacturer Received02/02/2024
02/14/2024
Supplement Dates FDA Received02/02/2024
02/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)
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