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 2017-06-30 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[79150470]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[79150491]
The customer received a questionable lipc lipase colorimetric assay result for one patient sample. The sample in question was hemolyzed and the lipase result was 228 u/l. This result was reported outside the laboratory and was questioned by the physician who said the result did not correlate to the clinical situation for the patient. A new sample was drawn from the patient on (b)(6) 2017 and the lipase result was 38 u/l. A new sample was drawn from the patient on (b)(6) 2017 and the lipase result was 21 u/l. These samples were not hemolyzed. There was no allegation of an adverse event. The reagent lot number was 247189. The expiration date was requested but was not provided. The customer thinks the erroneous high lipase result may have been due to the hemolysis of the sample.
Patient Sequence No: 1, Text Type: D, B5
[132620441]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. The effect of hemolysis on the result was ruled out based on the data provided. As calibration and qc was within range, a reagent or instrument problem could be excluded. Most likely, there was another sample specific issue or carry-over which caused the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01387 |
| MDR Report Key | 6681540 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-30 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2017-06-19 |
| Date Added to Maude | 2017-06-30 |
| 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 |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHI |
| Date Received | 2017-06-30 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-30 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 | 2017-06-30 |