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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY CLINICAL CHEMISTRY GLUCOSE
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ABBOTT GERMANY CLINICAL CHEMISTRY GLUCOSE Back to Search Results
Catalog Number 07P55-20
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2019
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete sid: (b)(6).All available patient information was included.Additional patient details are not available.
 
Event Description
The customer reported a falsely decreased glucose result generated on the alinity c analyzer on one (b)(6) female patient.Results provided: sid (b)(6), (b)(6) 2019 = 28.557 / 367.804 / another alinity = 365.545 mg/dl.No impact to patient management was reported.
 
Manufacturer Narrative
Return testing was not completed as returns were not available.A review of ticket trending did not identify any complaints that were similar for falsely depressed glucose patient results.The trend review by the product list number found no trends related to this issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no product deficiency was identified.
 
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Brand Name
CLINICAL CHEMISTRY GLUCOSE
Type of Device
GLUCOSE
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8910060
MDR Text Key158975872
Report Number3002809144-2019-00514
Device Sequence Number1
Product Code CFR
UDI-Device Identifier00380740135447
UDI-Public00380740135447
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Catalogue Number07P55-20
Device Lot Number53466UQ08
Was Device Available for Evaluation? No
Date Manufacturer Received08/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALINITY C ANALYZER LIST 03R67-01; ALINITY C ANALYZER LIST 03R67-01; SERIAL AC01791; SERIAL AC01791
Patient Age60 YR
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