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 2017-07-27 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[81151227]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[81151228]
The customer obtained questionable results for one patient sample using the elecsys ca 125 ii assay (ca 125), and for one patient using the elecsys myoglobin stat immunoassay (myo stat), on the cobas 6000 e 601 module. Of the data provided, only the results for ca 125 were a reportable malfunction. None of the results were released outside of the laboratory. The initial ca 125 result was 81. 85 u/ml. The sample was repeated twice with results of 156. 6 u/ml and 162. 4 u/ml. No data flags or alarms occurred with any of the results. The final result was deemed correct. There was no allegation that an adverse event occurred. The ca 125 reagent lot number is 187489; the expiration date was not provided. The customer ran sample cups on top of a 13mm tube. This may lead to insufficient sample aspiration and/or incorrect liquid level detection signal without any alarms. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[119940718]
The expiration date for ca 125 reagent lot number of 187489 is feb-2018. Calibration and quality controls were acceptable. The customer did not use rack adapters and ran sample cups on top of a 13 mm tube. A specific root cause was not identified. A general product problem can be excluded. The most likely root cause is related to the customer using non-standard sample cups on top of a 13 mm tube without rack adapters. Additional possible root causes for this event may be sample quality and insufficient maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01534 |
| MDR Report Key | 6746313 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-27 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-07-06 |
| Date Mfgr Received | 2017-07-06 |
| Date Added to Maude | 2017-07-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTK |
| Date Received | 2017-07-27 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 |
| Brand Name | COBAS 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-27 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2017-07-27 |