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U.S. Department of Health and Human Services

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

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ABBOTT GMBH ARCHITECT HAVAB-G REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) Back to Search Results
Catalog Number 06C29-22
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2020
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: (b)(6). Completed information: (b)(6). No further patient information was provided by the customer. 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 6c29 that has a similar product distributed in the us, list number 6l27.
 
Event Description
The customer observed false reactive architect havab-igg results for multiple samples. Additionally, the customer reported inconsistent values for the assay between their two architect analyzers (serial numbers (b)(4)) including the control material. The customer completed a weekly repeat of the following sample on both analyzers. The customer believes the samples were stored correctly prior to the repeat testing. It is unknown which analyzer generated the initial results (units of measure
=
s/co, reference range: greater than or equal to 1. 0 s/co
=
reactive): (b)(6) 2020; sid: (b)(6) original result
=
0. 83, repeats on isr53089
=
0. 83, 1. 00, and 1. 03, repeats on isr53090
=
0. 85, 0. 86, and 0. 88 no impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-G 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 Key10738705
MDR Text Key213176305
Report Number3002809144-2020-01054
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
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 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/23/2020
Device Catalogue Number06C29-22
Device Lot Number09449BE00
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 Received12/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
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: 10/27/2020 Patient Sequence Number: 1
Treatment
ARC I2000SR INST, 03M74-02, ISR53089
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