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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CALCIUM

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ABBOTT GERMANY ALINITY C CALCIUM Back to Search Results
Catalog Number 07P57-20
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2019
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is completed.The initial report was submitted under manufacturer report number 1628664-2019-00525 ((b)(4), usa as manufacturing site).Upon retrospective review, it was discovered that mfr information was incorrect.This report was created to correct the site of manufacturer ((b)(4)).
 
Event Description
The account generated false elevated alinity c calcium of 3.7, 2.6 mmol/l that repeated 2.0, 1.9, 2.0, 2.0 mmol/l on the same and other analyzers with sample id (b)(6).The account uses a normal range of 2.1 to 2.55 mmol/l.No specific patient information was provided.No impact to patient management was reported.
 
Manufacturer Narrative
A review of the complaint database found no similar complaints for the suspect lot.Also no atypical complaint trends for calcium list number 7p57 were identified.No non-conformances or deviations were identified for list number 7p57.A review of the product labeling concluded that the issue is sufficiently addressed.No customer returns were available for evaluation.The issue appears to be isolated to this sample.No product deficiency was identified.
 
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Brand Name
ALINITY C CALCIUM
Type of Device
CALCIUM
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8872489
MDR Text Key154122284
Report Number3002809144-2019-00491
Device Sequence Number1
Product Code CJY
UDI-Device Identifier00380740132613
UDI-Public00380740132613
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 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/11/2019
Device Catalogue Number07P57-20
Device Lot Number63032UN18
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/05/2019
Initial Date FDA Received08/07/2019
Supplement Dates Manufacturer Received08/30/2019
Supplement Dates FDA Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALINITY C LIST 03R67-01; ALINITY C LIST 03R67-01; SERIAL AC01097; SERIAL AC01097
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