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 2017-09-15 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[87308098]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87308099]
The customer stated that they had been having intermittent issues with low values for an unspecified number of patient samples tested for ise indirect k for gen. 2 (potassium) on a cobas 6000 c (501) module - c501. The customer provided data for two patient samples that had questionable initial potassium results. Of these, one had an erroneous potassium result that was reported outside of the laboratory. The sample was repeated and the repeat result was believed to be correct. The sample initially resulted as 3. 3 mmol/l and repeated as 4. 0 mmol/l. The patient was not adversely affected. The potassium electrode lot number and expiration date were asked for, but not provided. The field service engineer determined there was a fluidic failure of the analyzer as the vacuum pressure was too low. The vacuum line at the vacuum vessel was not attached. He replaced and re-attached the vacuum line, replaced vacuum diaphragms. He replaced the ise sipper, sipper cover, and spring. He verified the fluidics dispense and probe alignment. A mechanism check was performed and this passed. The customer ran calibration and quality controls. Controls were near mean values. The instrument was determined to be performing within specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01998 |
| MDR Report Key | 6868054 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-08-27 |
| Date Mfgr Received | 2017-08-27 |
| Date Added to Maude | 2017-09-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEM |
| Date Received | 2017-09-15 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-15 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2017-09-15 |