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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

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ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) Back to Search Results
Catalog Number 06C30-22
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. All available patient information was included. Additional patient details are not available.
 
Event Description
The customer stated that results using the architect havab-igm assay have increased slightly since the customer started using new reagent lot 19112be00. Data for one sample was provided. Sample id6000059566: 0. 88 s/co grayzone reactive, 0. 9 s/co grayzone reactive and 0. 92 s/co grayzone reactive. Grayzone range is 0. 8 - 1. 2 s/co. The customer received new reagent lot 19467be00 and retested the sample. The retest result was 0. 6 s/co negative. The sample was tested at another laboratory and the result was positive. No adverse impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-M REAGENT KIT
Type of DeviceHEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
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 Key10953341
MDR Text Key232569335
Report Number3002809144-2020-01162
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
N/A
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 01/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/12/2021
Device Catalogue Number06C30-22
Device Lot Number19467BE00
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 Received01/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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