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 2017-07-17 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[80286966]
Unique identifier (udi)#: (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[80286967]
The customer questioned results for 1 patient sample tested for astl aspartate aminotransferase acc. To ifcc without pyridoxal phosphate activation (astl) and altl alanine aminotransferase - pyridoxal phosphate activated (altl) on a cobas 6000 c (501) module. Based on the data provided, the astl results were erroneous and reported outside of the laboratory. The initial astl result was 21 u/l with a data flag. The sample was repeated and the result was < 5 u/l with a data flag. The result of <5 u/l was reported outside of the laboratory. On (b)(6)2017 the sample was repeated after ultra-centrifuging and the result was 20 u/l. The result of 20 u/l was released outside of the laboratory as a corrected result. The customer stated that the lipemia index, as measured by the c501 analyzer, was 153 for this sample where the cutoff for astl is 150, per product labeling. The sample was visually very lipemic. The customer was not sure which result was correct. She is wondering if ultra-centrifuging is an approved method for handling lipemic samples. No adverse event occurred. The astl reagent lot number was (b)(4) with an expiration date of 05/31/2018. Calibration and quality controls were acceptable. The field service engineer (fse) visited the customer site and found an issue with the sample probe. The sample probe was cleaned. A check test was performed and all results were within the acceptable range. The instrument was functioning per specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01468 |
| MDR Report Key | 6718768 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-17 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-23 |
| Date Added to Maude | 2017-07-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIT |
| Date Received | 2017-07-17 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-17 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-17 |