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 2017-08-30 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[83996345]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83996346]
The customer received a questionable ldhi2 lactate dehydrogenase acc. To ifcc ver. 2 result for one patient sample. The initial patient result was 100 u/l and was reported outside the laboratory. A few hours later a new sample from the same patient was tested for ldh. The result with an automatic dilution was 1597 u/l. As the customer noted the patient? S ldh results had been around 1500 u/l, he repeated the initial sample and the result with an automatic dilution was 1756 u/l. There was no adverse event. The ldh reagent lot number and expiration were requested but were not provided. The field service engineer suspected a possible sample issue. He performed a baseline check, checked all probe alignments, and rinsing. He checked cuvette water level, pump pressure, reagent air purge volume, and detergent concentration. All of the checks were acceptable. A precision check was performed on ldh with pooled serum. Results were all in within specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01867 |
| MDR Report Key | 6830867 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-30 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-08-08 |
| Date Mfgr Received | 2017-08-11 |
| Date Added to Maude | 2017-08-30 |
| 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 8000 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-08-30 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 8000 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-30 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 | 2017-08-30 |