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 2017-08-17 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[83797067]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83797068]
The customer obtained a questionable high result for one patient sample using the elecsys calcitonin immunoassay (calc) on the cobas 8000 e 602 module. All results are in units of pg/ml. No data flags or alarms occurred unless otherwise specified. The initial result was 2000 with a data flag. The sample was automatically diluted and repeated with a result of 53263. This result was released outside the laboratory to the clinician. The clinician requested that the sample be checked and repeated, since this result was much larger than the patient's previous results. The customer manually diluted the sample and obtained the following results: 34625 (25x dilution), 31740 (50x dilution), and 25900 (100x dilution). These results were more in line with the patient's results from two weeks prior to the event. There was no allegation that an adverse event occurred. The calc reagent lot number and expiration date were not provided; however, the reagent pack was expired at the time of the event. Calibration was acceptable. The number of measuring cell determinations was very high. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01728 |
| MDR Report Key | 6800837 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-17 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-08-17 |
| 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 | 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JKR |
| Date Received | 2017-08-17 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-17 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 | 2017-08-17 |