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 2017-09-28 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[89480617]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89480618]
The customer stated that they had received an erroneous ldhi2 lactate dehydrogenase acc. To ifcc ver. 2 result for one patient sample on the cobas 6000 c (501) module. The patient sample was repeated the next day for reagent lot comparison. The initial ldhi2 result was 323 u/l and was reported outside the laboratory. The repeat results on the same c501 module and another c501 module were 176 u/l, 169 u/l, 180 u/l, and 174 u/l. The repeat results were deemed to correct. Information regarding any adverse event was requested but was not provided. The ldhi2 reagent lot number was 18597001 with an expiration date of 30-sep-2017. The field service engineer (fse) was not able to determine the cause. The fse performed a baseline, replaced multiple parts, and preventative maintenance on the c501. The fse ran a precision check that was satisfactory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02135 |
| MDR Report Key | 6900173 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-28 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-07-31 |
| Date Mfgr Received | 2017-09-11 |
| Date Added to Maude | 2017-09-28 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-09-28 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-28 |
| 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 | 2017-09-28 |