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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

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ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM Back to Search Results
Catalog Number 03L79-21
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific patient information was provided.
 
Event Description
The customer reported a falsely elevated architect calcium result.Sample id ia0900329ss generated an initial result of 10.92 meq/l.The sample was retested multiple times ranging from 3.51 meq/l to 4.98 meq/l.The customer uses a normal range of 4.09 to 5.58 meq/l.No specific patient information was provided.No adverse impact to patient management was reported.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Update 04dec2018: section, catalog # updated to 03l79-21.
 
Manufacturer Narrative
Review of the complaint activity for the calcium assay did not identify atypical complaint activity.The customers instrument logs were reviewed.This review found the customer does not perform all the required maintenance on the architect c8000 analyzer.During the review no identifiable quality control sample analysis was found.The lack of routine instrument maintenance and quality control testing may have contributed to the customers issue.Manufacturing documentation for the calcium assay did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customers issue.No systemic issue or deficiency of the architect calcium assay was identified.
 
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Brand Name
CLINICAL CHEMISTRY CALCIUM
Type of Device
CALCIUM
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
MDR Report Key8006894
MDR Text Key125913676
Report Number1628664-2018-01972
Device Sequence Number1
Product Code CJY
UDI-Device Identifier00380740005948
UDI-Public00380740005948
Combination Product (y/n)N
PMA/PMN Number
K981578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 01/17/2019
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 Date02/27/2019
Device Catalogue Number03L79-21
Device Lot Number98314UN17
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/10/2018
Initial Date FDA Received10/25/2018
Supplement Dates Manufacturer Received11/12/2018
01/09/2019
Supplement Dates FDA Received12/04/2018
01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT C8000, LIST 01G06-11; ARCHITECT C8000, LIST 01G06-11; ARCHITECT C8000, LIST 01G06-11; SERIAL C802810; SERIAL C802810; SERIAL C802810
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