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 2017-10-16 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[90542639]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90542640]
The customer stated they were receiving "very high" ldhi2 lactate dehydrogenase acc. To ifcc ver. 2 since (b)(6) 20174 on the cobas 6000 c (501) module. The customer stated that they have calibrated multiple times, have not changed reagent lot, and their quality control is "running high". The customer provided an erroneous result for one patient sample. The initial ldhi2 result was 168 u/l and the repeat result was 263 u/l. The erroneous result was reported outside of the laboratory however there was no adverse event. Repeat testing was performed on the same c501 module and deemed to be correct. The ldhi2 reagent lot number was 15597001 with an expiration date of 30-sep-2017. The field service engineer (fse) found loose fittings that hold one of the reagent probes in place. The fse tightened the probe holder fittings, checked the internal rinse volume through all probes, and checked the gear pump pressure. All were within specifications. The vacuum diaphragms were replaced during the yearly preventative maintenance in (b)(6). The fse changed the rinse mechanism tubing, checked the water/detergent dispense levels, and checked the probe alignments. The fse recalibrated the ldhi2 assay, ran quality control, and precision which passed. Trending was performed on this type of event and no abnormal trend was identified. During a review for this customer site, there were no similar past complaints on any like instrument for the past 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02317 |
| MDR Report Key | 6951042 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-09-28 |
| Date Added to Maude | 2017-10-16 |
| 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 | 0 |
| 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 | CFH |
| Date Received | 2017-10-16 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-16 |