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 2017-06-09 for COBAS 6000 E 601 MODULE E601 manufactured by Roche Diagnostics.
[77540307]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77540308]
The customer obtained a questionable high result for one patient sample using the elecsys testosterone ii assay (test) on the cobas 6000 e 601 module. All results are in units of ng/ml, and all were released to the physician. The initial result was 5. 17. The sample was then stored at 2-8 degrees celsius. The physician did not believe the result since the patient is female. On (b)(6) 2017, the physician requested a repeat result. The sample was beyond the stability time point for storage at 2-8 degrees celsius per product labeling; however, the customer repeated the sample with results of 0. 041 and 0. 044. On (b)(6) 2017, the customer analyzed an aliquot of the original sample that had been stored frozen at -20 degrees celsius. The result was 0. 040. There was no allegation that an adverse event occurred. The test reagent lot number is 137627; the expiration date was not provided. Quality controls were acceptable prior to and after the event. Calibration was last performed on (b)(6) 2017. Alarm information was reviewed and contained two "abnormal probe sucking" and some "sample short" alarms. There was no fibrin or clots observed in the sample. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[120146819]
The field service representative conducted assay performance testing which was acceptable. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A possible root cause for the non-reproducible false high result is a pre-analytical issue. Additional possible root causes may be improper handling of the reagent or system reagents, or contamination of the environment with the analyte.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01193 |
| MDR Report Key | 6630590 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-09 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-09 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CDZ |
| Date Received | 2017-06-09 |
| Model Number | E601 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-09 |
| Model Number | E601 |
| 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 | 2017-06-09 |