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 2017-10-17 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[90649402]
Unique identifier (udi)# (b)(4). The event occurred (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90649403]
The customer complained of questionable results for hdlc3 hdl-cholesterol plus 3rd generation, trigl triglycerides (trigl), and ureal urea/bun for one patient sample. Of the data provided only the data for trigl is a reportable malfunction. The initial trigl result was 1 mg/dl and was reported outside of the laboratory. The trigl testing was repeated on (b)(6) 2017 and a result of 201 mg/dl was obtained. The repeat result was deemed to be correct as a corrected report was issued. There was no allegation of an adverse event. The trigl reagent lot was 22259201 with an expiration date of 28-feb-2018. A specific root cause could not be identified. Further investigation showed that since the issue occurred only once and calibration and qc data appeared acceptable, a general reagent or hardware issue was excluded. The reaction kinetics show that an insufficient sample may have been pipetted which could have resulted in the low test result. Therefore the cause was assumed to be preanalytical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02344 |
| MDR Report Key | 6954105 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-09-24 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-10-17 |
| 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 | CHH |
| Date Received | 2017-10-17 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |