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 2017-11-02 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[91928619]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91928620]
The customer stated that they received a discrepant gluc3 glucose hk result for a patient sample on the cobas 6000 c (501) module. The initial glucose result was 768 mg/dl with a data flag. The sample was automatically rerun on the c501 module with a glucose result of 125 mg/dl and was reported outside the laboratory. The result was questioned by the emergency room staff. A different sample from the same patient was run with a glucose result of 700 mg/dl and was deemed to be correct. Repeat testing was performed on the same c501 module. There was no adverse event. The glucose reagent lot number was 25244601 with an expiration date of 30-sep-2018. The field service engineer (fse) could not determine a root cause. The fse checked the adjustments of the c501 module and ran precision that were within specifications. The customer ran calibration and quality control that were within specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02505 |
| MDR Report Key | 6995839 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-02 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-10-17 |
| Date Added to Maude | 2017-11-02 |
| 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 |
| 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 | CFR |
| Date Received | 2017-11-02 |
| 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 | 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 | 2017-11-02 |