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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S SYPHILIS REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

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ABBOTT GMBH ALINITY S SYPHILIS REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Catalog Number 06P09-55
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: sid (b)(6) (same patient / 2 different samples). This report is being filed on an international product, list number 06p09-55 that has a similar product distributed in the us, list number 8d06-31/-41. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported a false nonreactive alinity s syphilis tp result for a donor who has a medical history of being reactive when tested for syphilis previously. The following data was provided (reference range: < 1. 00 s/co is nonreactive, >/
=
1. 00 s/co is reactive): on (b)(6) 2022 sid (b)(6): initial result: 6. 79 s/co (alinity 2 as1082); repeat results: 7. 22, 6. 92 s/co (alinity 1 as1245 on (b)(6) 2022) on (b)(6) 2022, same donor enters as a patient by the doctor¿s request: sid (b)(6): initial result: 0. 70 s/co, result released as nonreactive (alinity 3 as1292) the doctor questioned this result and both samples were retested. The repeat results were: (b)(6) 2022: sid (b)(6) (second sample): 7. 13 s/co (alinity 3 as1292). Sid (b)(6) (second sample): 7. 45 s/co (alinity 1 as1245). On (b)(6) 2022: sid (b)(6) (first sample): 6. 07 s/co (alinity 1 as1245) there was no impact to patient management reported.
 
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Brand NameALINITY S SYPHILIS REAGENT KIT
Type of DeviceENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key15097585
MDR Text Key298198338
Report Number3002809144-2022-00259
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 08/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/12/2022
Device Catalogue Number06P09-55
Device Lot Number31359BE00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/25/2022 Patient Sequence Number: 1
Treatment
ALNTY S SYSTEM, 06P16-01, AS1292
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