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 2017-07-24 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[80904089]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). Initial reporter phone number was provided as "(b)(6)".
Patient Sequence No: 1, Text Type: N, H10
[80904090]
The customer stated that they received questionable results for an unspecified number of patient samples tested for multiple assays on the cobas 6000 c (501) module - c501. The customer provided data for a total of 23 patient samples and of these, 13 had erroneous results that were reported outside of the laboratory for chol2 cholesterol gen. 2 (chol), trigl triglycerides (trig), and ldl_c ldl-cholesterol plus 3rd generation (ldl). The initial results were reported outside of the laboratory. The field service engineer checked rinse pressures and reaction cell fill levels. The engineer performed several probe purges. The probe was blocked, so it was changed. The customer then ran quality controls and these were within range. The samples were repeated after the service activities were performed and the repeat results were considered to be correct. No adverse events were alleged. The chol reagent lot number was 236242. The trig reagent lot number was 236112. The ldl reagent lot number was 173247. The reagent expiration dates were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01519 |
| MDR Report Key | 6737245 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-24 |
| Date of Report | 2017-07-24 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-07-04 |
| Date Added to Maude | 2017-07-24 |
| 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 |
| 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 | CHH |
| Date Received | 2017-07-24 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-07-24 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-07-24 |