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 2017-07-12 for COBAS 6000 E 601 MODULE E601 manufactured by Roche Diagnostics.
[80079436]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80079437]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys testosterone ii assay (testo) on a cobas 6000 e 601 module (e601). The sample initially resulted with a value > 20 nmol/l. The initial result was reported outside of the laboratory to the physician. The value was questioned, so a new sample was collected from the patient and tested, resulting with a normal value of "< 05" nmol/l. The original sample was then repeated and they received a low result similar to that of the new sample collection. No adverse events were alleged to have occurred with the patient. The testo reagent lot number was 191053. The reagent expiration date was asked for, but not provided. The field service engineer stated that there were no error messages generated by the analyzer, so a technical issue with the analyzer was not likely. The customer admitted that they used pooled reagent for the sample measurement. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. The use of pooled reagents is outside of roche recommendations and may potentially cause high sample results. Other possible root causes for this event may be improper handling of the reagent or system reagents, or contamination of the environment with the analyte.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01452 |
| MDR Report Key | 6705604 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-12 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-06-27 |
| Date Added to Maude | 2017-07-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-07-12 |
| Model Number | E601 |
| Catalog Number | ASKU |
| 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 | 2017-07-12 |
| Model Number | E601 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-07-12 |