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U.S. Department of Health and Human Services

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

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ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Catalog Number 07P60-32
Device Problems False Negative Result (1225); False Positive Result (1227)
Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number (b)(4) that has a similar product distributed in the us, list number (b)(4). Section a: multiple identifiers for the single patient (blood donor): (b)(6) and (b)(6). No information regarding the blood unit recipient is available at this time.
 
Event Description
The customer generated false nonreactive alinity i syphilis tp results for one patient. The following data was provided: on (b)(6) 2020 sid (b)(4) initial result 0. 65 s/co (nonreactive). On (b)(6) 2021 sid (b)(4) (same patient as sid 2006571) initial result 1. 11 s/co (reactive), repeated 1. 17 s/co (reactive) and 1. 10 s/co (reactive). On (b)(6) 2021 retested from (b)(6) 2020 sid (b)(4) sample, initial result 1. 10 s/co (reactive), repeat 1. 13 s/co (reactive). The false negative result occurred on a blood donation. The blood unit has subsequently been transfused into another patient prior to identification of the false negative result. No other information regarding patient outcome is available.
 
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Brand NameALINITY I SYPHILIS TP 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
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key11241143
MDR Text Key233258961
Report Number3002809144-2021-00062
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodePO
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/24/2021
Device Catalogue Number07P60-32
Device Lot Number20451BE00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/27/2021 Patient Sequence Number: 1
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