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 2017-09-29 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[89489165]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89489166]
The customer received questionable ise indirect k for gen. 2 results for a patient? S serum sample compared to the same patient? S plasma sample on the cobas 6000 c (501) module. The serum and plasma tubes were drawn at the same time and tested on the same c501 module. The initial serum sample k result was 6. 4 mmol/l and the repeat plasma sample k result was 5. 5 mmol/l. It was asked but not known which result was deemed to be correct. The patient? S serum and plasma samples were sent to another laboratory and the customer stated they received the same k results for the serum and plasma samples. No results were reported outside the laboratory and there was no adverse event. The k electrode lot number and expiration date were requested but not provided. The customer stated they suspect that this could potentially be a patient sample specific issue. The customer ran serum and plasma samples collected from a different patient and the results matched. The customer recalibrated and ran quality control. The customer ran the same questionable patient serum and plasma samples again. The customer received the same k results for each respective sample. The field service engineer (fse) checked the ise system, ise flow path, o-rings, cartridges, and acrylic blocks. All were in place. The fse ran an ise check and the customer ran calibration and quality control that were within specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02145 |
| MDR Report Key | 6903457 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-29 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-09-29 |
| 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 | 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEM |
| Date Received | 2017-09-29 |
| 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 | 2017-09-29 |
| 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 | 2017-09-29 |