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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY I HAVAB IGM REAGENT KIT
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ABBOTT GERMANY ALINITY I HAVAB IGM REAGENT KIT Back to Search Results
Catalog Number 02R28-32
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2019
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer stated that a (b)(6) alinity i havab igm result of (b)(6) was generated for a patient sample that tested (b)(6) using alternate methods (biomerieux vidas, beckman dxl, diasorin liaison xl, siemens advia centaur and roche cobas e4).No adverse impact to patient management was reported.
 
Manufacturer Narrative
No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Historical lot search and/or file kit testing could not be performed as the likely cause lot number is unknown.Based on the available information, no product deficiency was identified.
 
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Brand Name
ALINITY I HAVAB IGM REAGENT KIT
Type of Device
HAVAB IGM
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8827202
MDR Text Key152936479
Report Number3002809144-2019-00468
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
PMA/PMN Number
K063329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02R28-32
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALINITY I PROCESSING MODULE; ALINITY I PROCESSING MODULE; LIST 03R65-01, SERIAL (B)(4); LIST 03R65-01, SERIAL (B)(4)
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