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 2017-08-04 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[83109464]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83109465]
The customer obtained questionable test results for one patient sample using the ast aspartate aminotransferase acc. To ifcc without pyridoxal phosphate activation (ast) and ise indirect na, k, ci for gen. 2 (potassium) assays. The initial results were released outside of the laboratory. The analyst attempted to repeat the sample twice, but received sample short errors and data flags which invalidated the results. The sample repeated successfully on the third repeat attempt, and corrected reports were issued with the repeat results. The initial ast result was 12. 7 u/l; repeat result was 29. 4 u/l. The initial potassium result was 6. 44 mmol/l. Since this result was high, the sample was repeated with a result of 4. 03 mmol/l. There was no allegation that an adverse event occurred. The ast reagent lot number and expiration date were not provided. The potassium electrode lot number is e96; the expiration date was not provided. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01591 |
| MDR Report Key | 6766558 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-04 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-07-16 |
| Date Mfgr Received | 2017-07-16 |
| Date Added to Maude | 2017-08-04 |
| 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 | CIT |
| Date Received | 2017-08-04 |
| 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 | 2017-08-04 |
| 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 | 2017-08-04 |