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 2017-10-30 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[91446201]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91446202]
The customer received questionable high chol2 cholesterol gen. 2 results for 11 patient samples. Data was only provided for four patient samples. Patient 1 initial result was 607 mg/dl and the repeat result was 224 mg/dl. Patient 2 initial result was 417 mg/dl and the repeat result was 117 mg/dl. Patient 3 initial result was 575 mg/dl and the repeat result was 222 mg/dl. Patient 4 initial result was 495 mg/dl and the repeat result was 182 mg/dl. The erroneous results were reported outside the laboratory. The repeat results were believed to be correct. There was no adverse event. The reagent lot number was 26208301 with an expiration date of 31-mar-2018. The field service representative instructed the customer to performed precision testing which was within specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02464 |
| MDR Report Key | 6988208 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-30 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2017-10-13 |
| Date Added to Maude | 2017-10-30 |
| 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 | 0 |
| 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 | CHH |
| Date Received | 2017-10-30 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-30 |