MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-22 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[88232088]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[88232089]
The customer complained of an erroneous high result for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module. The initial gluc3 result was 153. 6 mg/dl. This result was reported outside of the laboratory where the doctor questioned it. On (b)(6) 2017 the sample was repeated and the result was 113. 4 mg/dl. On (b)(6) 2017 the sample was repeated again and the result was 108. 0 mg/dl. There was no allegation that an adverse event occurred. The gluc3 reagent lot number was 254446 with an expiration date of 30-sep-2018. Calibration and quality controls (qc) were acceptable. No issues were identified during a review of alarm trace data. Based on the reaction monitor provided, the initial high result showed a general higher absorbance. The high result may have been due to more sample pipetted into the reaction cell. Based on the precision data provided, there may be issues with the reagent pipettor or the rinse units. A specific root cause was not identified. Since calibration and qc data was acceptable, a general reagent issue is not suspected. Based on the information available, the most likely root cause is related to pre-analytics or deposits on the sample probe. Too much sample could have been transferred due to fibrin strands which can be caused by improper primary tube handling or coagulation/centrifugation issues related to the sample probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02043 |
| MDR Report Key | 6885792 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-09-22 |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFR |
| Date Received | 2017-09-22 |
| Model Number | C501 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |