MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-02 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[68977711]
Unique identifier (udi)#: (b)(4). Component code - device subassembly = sampling.
Patient Sequence No: 1, Text Type: N, H10
[68977713]
The customer stated that they received an erroneous result for one patient sample tested for phos2 phosphate (inorganic) ver. 2 - phos on a cobas 6000 c (501) module - c501. The sample was collected, centrifuged, and measured. Approximately 4 1/2 hours later, the phos test was ordered and the sample was put back on the instrument for initial phos measurement. The sample initially resulted as 0. 5 mg/dl accompanied by a data flag and this value was reported outside of the laboratory. The sample was repeated, resulting as 3. 6 mg/dl. The repeat result was believed to be correct. The patient was not adversely affected. The phos reagent lot number was 19635201, with an expiration date of 01/31/2018. The field service engineer could not determine a cause, but he suspected that the sampling assembly was damaged. He replaced the sampling assembly and a pump head for troubleshooting purposes. He ran precision testing. The customer ran calibrations. All controls were acceptable to the customer and the system was found to be performing within specifications.
Patient Sequence No: 1, Text Type: D, B5
[69978635]
A specific root cause could not be determined based on the provided information. The customer did not have any further issues after the actions performed by the field service engineer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00450 |
| MDR Report Key | 6373326 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-02-11 |
| Date Mfgr Received | 2017-02-11 |
| Date Added to Maude | 2017-03-02 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEO |
| Date Received | 2017-03-02 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-02 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2017-03-02 |