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.
[91929503]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91929504]
He customer stated that they had received a discrepant gluc3 glucose hk result for a patient sample on the cobas 6000 c (501) module. The initial glucose result was 47 mg/dl and was reported outside of the laboratory. The customer observed data flags with other results and reran the sample on the same c501 module. The repeat glucose result was 91 mg/dl and deemed to be correct. The customer observed the issue and contacted the physician immediately with the correct result. No patient was affected. The glucose reagent lot number was 23629001 with an expiration date of 31-july-2018. At the same occurrence the customer received trigl triglycerides results with data flags for two patient samples but did not provide the data. The results were not reported outside of the laboratory and the patients were not affected. The samples were repeated with valid results. There were no adverse events. The field service engineer (fse) could not determine a root cause. The fse performed a precision check that was "okay". The customer ran calibration and quality control which recovered as expected. The customer reran 20 patient samples and all samples "matched" the initial result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02508 |
| MDR Report Key | 6996012 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-02 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-10-16 |
| 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 |
| 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 | * |
| 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 |