COBAS 6000 C501 MODULE 05860636001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-02 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.

Event Text Entries

[68977711] Unique identifier (udi)#: (b)(4). Component code - device subassembly = sampling.
Patient Sequence No: 1, Text Type: N, H10


[68977713] The customer stated that they received an erroneous result for one patient sample tested for phos2 phosphate (inorganic) ver. 2 - phos on a cobas 6000 c (501) module - c501. The sample was collected, centrifuged, and measured. Approximately 4 1/2 hours later, the phos test was ordered and the sample was put back on the instrument for initial phos measurement. The sample initially resulted as 0. 5 mg/dl accompanied by a data flag and this value was reported outside of the laboratory. The sample was repeated, resulting as 3. 6 mg/dl. The repeat result was believed to be correct. The patient was not adversely affected. The phos reagent lot number was 19635201, with an expiration date of 01/31/2018. The field service engineer could not determine a cause, but he suspected that the sampling assembly was damaged. He replaced the sampling assembly and a pump head for troubleshooting purposes. He ran precision testing. The customer ran calibrations. All controls were acceptable to the customer and the system was found to be performing within specifications.
Patient Sequence No: 1, Text Type: D, B5


[69978635] A specific root cause could not be determined based on the provided information. The customer did not have any further issues after the actions performed by the field service engineer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2017-00450
MDR Report Key6373326
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-03-02
Date of Report2017-03-14
Date of Event2017-02-11
Date Mfgr Received2017-02-11
Date Added to Maude2017-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
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 C501 MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeCEO
Date Received2017-03-02
Model NumberC501
Catalog Number05860636001
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 C501 MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-03-02
Model NumberC501
Catalog Number05860636001
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 2017-03-02

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