MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-15 for COBAS 6000 C501 MODULE 04745914001 manufactured by Roche Diagnostics.
[5941786]
Reported that they received erroneous results for one patient sample tested for ion selective electrode (ise) sodium and ise chloride. The sample initially resulted as 95 mmol/l for ise sodium and 127. 5 mmol/l for ise chloride. The initial results were reported outside of the laboratory as 95 mmol/l for ise sodium and 128 mmol/l for ise chloride. The sample was repeated and resulted as 128 mmol/l for ise sodium and 86. 7 mmol/l for ise chloride. The sample was repeated a second time and resulted as 126 mmol/l for ise sodium and 85. 6 mmol/l for ise chloride. The sample was recentrifuged and repeated a third time and resulted as 127 mmol/l for ise sodium and 85. 5 mmol/l for ise chloride. The patient was not adversely affected. The ise sodium and ise chloride electrode lot numbers and expiration dates were asked for, but not provided. The customer performed a precision check for ise sodium and ise chloride; the results were ok. A specific root cause could not be determined based on the provided information. The information suggests that there was a disturbance in the potassium chloride sipper flow path.
Patient Sequence No: 1, Text Type: D, B5
[13354033]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03620 |
| MDR Report Key | 4843976 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-15 |
| Date of Report | 2015-06-15 |
| Date of Event | 2015-05-26 |
| Date Mfgr Received | 2015-05-26 |
| Date Added to Maude | 2015-06-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 | CGZ |
| Date Received | 2015-06-15 |
| Model Number | NA |
| 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 46250 US 46250 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-06-15 |
| Model Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-15 |