COBAS 6000 C (501) MODULE C501 04745914001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-04 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.

Event Text Entries

[83109464] (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[83109465] The customer obtained questionable test results for one patient sample using the ast aspartate aminotransferase acc. To ifcc without pyridoxal phosphate activation (ast) and ise indirect na, k, ci for gen. 2 (potassium) assays. The initial results were released outside of the laboratory. The analyst attempted to repeat the sample twice, but received sample short errors and data flags which invalidated the results. The sample repeated successfully on the third repeat attempt, and corrected reports were issued with the repeat results. The initial ast result was 12. 7 u/l; repeat result was 29. 4 u/l. The initial potassium result was 6. 44 mmol/l. Since this result was high, the sample was repeated with a result of 4. 03 mmol/l. There was no allegation that an adverse event occurred. The ast reagent lot number and expiration date were not provided. The potassium electrode lot number is e96; the expiration date was not provided. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-01591
MDR Report Key6766558
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-08-04
Date of Report2017-08-28
Date of Event2017-07-16
Date Mfgr Received2017-07-16
Date Added to Maude2017-08-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1HITACHI HIGH TECH CORP.
Manufacturer Street882 ICHIGE HITACHINAKA NA
Manufacturer CityIBARAKI 312-8504
Manufacturer CountryJA
Manufacturer Postal Code312-8504
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameCOBAS 6000 C (501) MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeCIT
Date Received2017-08-04
Model NumberC501
Catalog Number04745914001
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457

Device Sequence Number: 1

Brand NameCOBAS 6000 C (501) MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-08-04
Model NumberC501
Catalog Number04745914001
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-04

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