CLINICAL CHEMISTRY CALCIUM 03L79-21

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-25 for CLINICAL CHEMISTRY CALCIUM 03L79-21 manufactured by Abbott Manufacturing Inc.

Event Text Entries

[125913676] 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.
Patient Sequence No: 1, Text Type: N, H10


[125913677] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1628664-2018-01972
MDR Report Key8006894
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-10-25
Date of Report2019-01-17
Date Mfgr Received2019-01-09
Device Manufacturer Date2018-04-03
Date Added to Maude2018-10-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224667-512
Manufacturer G1ABBOTT MANUFACTURING INC
Manufacturer Street1921 HURD DRIVE
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLINICAL CHEMISTRY CALCIUM
Generic NameCALCIUM
Product CodeCJY
Date Received2018-10-25
Catalog Number03L79-21
Lot Number98314UN17
Device Expiration Date2019-02-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING INC
Manufacturer Address1921 HURD DRIVE IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-25

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