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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB-IGG IGG ANTI-HAV

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ABBOTT GERMANY ARCHITECT HAVAB-IGG IGG ANTI-HAV 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 Type  malfunction  
Manufacturer Narrative
Complete patient identifiers: (b)(6). All available patient information has been included. No additional patient details are available. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported false reactive (b)(6) igg results for two patients, when processing on the architect i2000sr. The following data was provided: sid (b)(6): isr52410 initial: 3. 25 s/co. Isr51772 retest: 0. 69 s/co. Isr52410 retest: 1. 13 s/co. Retest with isr52410 at a later date: 0. 91 s/co. Sid (b)(6): isr52410 initial: 4. 40 s/co. Isr51772 retest: 0. 82 s/co. Isr52410 retest: 2. 40 s/co. Retest with isr52410 at a later date: 0. 37 s/co. No impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-IGG
Type of DeviceIGG ANTI-HAV
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key9280118
MDR Text Key219780474
Report Number3002809144-2019-00811
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeJA
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 11/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/15/2020
Device Catalogue Number06C29-22
Device Lot Number03402BE00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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