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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-IGM IGM ANTI-HAV

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ABBOTT GMBH ARCHITECT HAVAB-IGM IGM ANTI-HAV Back to Search Results
Model Number N/A
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2020
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 06c30 that has a similar product distributed in the us, list number 6l21. Patient identifier: sid (b)(6).
 
Event Description
The customer observed a false nonreactive architect (b)(6) for a patient. On (b)(6) 2020 sid (b)(6) generated an initial result
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0. 84. S/co (grayzone); repeat result
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0. 77 s/co (nonreactive); on (b)(6) 2020 repeat result
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0. 93 s/co (grayzone). The sample was sent (b)(6) hospital for confirmation and generated a reactive result on an architect i2000sr analyzer. On (b)(6) 2020 the customer provided additional patient information: on (b)(6) 2020 sid (b)(6)
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initial result
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0. 81 s/co (grayzone), repeat results
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0. 77 s/co (nonreactive), 0. 93 s/co (grayzone), (b)(6) hospital for confirmation
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reactive.
 
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Brand NameARCHITECT HAVAB-IGM
Type of DeviceIGM ANTI-HAV
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, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key10468862
MDR Text Key232785925
Report Number3002809144-2020-00875
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeCA
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 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/09/2020
Device Model NumberN/A
Device Catalogue Number06C30-27
Device Lot Number14088BE00
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 Received09/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2020
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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