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 2017-07-07 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[79289231]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79289232]
The customer complained of erroneous low results for 6 patient samples tested for ggt-2 -glutamyltransferase ver. 2 standardized against ifcc / szasz (ggt-2) on a cobas 6000 c (501) module between (b)(6) 2017. The initial ggt-2 results for all 6 patient samples were < 3 u/l. The results were auto-validated and released outside of the laboratory. The samples were repeated and the ggt-2 results were "significantly higher. " refer to attached data for patient results. The results were amended once repeat testing was completed. There was no allegation that an adverse event occurred. The ggt-2 reagent lot number was 208541 with an expiration date of 09/30/2017. It was noted that samples were spun for 5 minutes at 3500 rpm. The lamp and measuring cells were replaced on (b)(6) 2017. The photometer check looked ok. Rinse tubing was replaced on (b)(6) 2017. There have been no visible signs of leaking since the rinse tubing was replaced. The samples involved in the event were checked and looked to be of good quality.
Patient Sequence No: 1, Text Type: D, B5
[119256049]
The customer provided specific data for the 6 patients affected. The customer initially alleged the initial ggt-2 results for all 6 patients were < 3 u/l. The actual initial ggt-2 result for 5 patients was (-)1 u/l with a data flag. The actual initial ggt-2 result for patient (b)(6) was 10 u/l. Calibration and qc data were acceptable. A review of the alarm trace showed "abnormal probe sucking" alarms. The field service engineer (fse) visited the customer site to check the instrument. The lamp, sample probe, syringe seals and heat cut filter were all replaced. The customer is not having problems with any other assays. It was noted that the primary sample tubes were used for all results. As far as the fse is aware, the gear pump head has never been replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01400 |
| MDR Report Key | 6692290 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-07 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-06-17 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-07 |
| 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 |
| 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 | JPZ |
| Date Received | 2017-07-07 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-07 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 | 2017-07-07 |