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 2017-11-03 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[92072245]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[92072246]
The customer received questionable high alb2 albumin gen. 2 results for one patient. The initial result was >63 g/l with a data flag. The sample was automatically repeated and the result was 72. 4 g/l. This result was reported outside the laboratory. The sample was repeated and the results were and >64. 6 g/l with a data flag and 77. 4 g/l with a decreased sample volume. The doctor complained about the reported result and the sample was tested at another laboratory and the result was 60 or 70 g/l. Electrophoresis was performed on the sample and the result was 64 g/l. The sample was also tested on an abbott analyzer and the result was 53 or 50 g/l. An additional result of 73. 8 g/l on (b)(6)2017 was provided but it was unclear if this was the same patient sample. The following additional results on (b)(6) 2017 were provided but it was unclear if this was the same patient sample. Initial result of 62. 9 g/l with a data flag and 70. 3 g/l, initial result of 63. 2 g/l with a data flag and 72. 1 g/l, initial result of 62. 4 g/l with a data flag and 69. 7 g/l, and initial result of 64. 8 g/l with a data flag and 70. 5 g/l. There was no allegation of an adverse event. The reagent lot number was 235818. The expiration date was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02521 |
| MDR Report Key | 6999290 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-03 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-11-03 |
| 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 |
| 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 | CJW |
| Date Received | 2017-11-03 |
| 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 | 2017-11-03 |