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 2017-08-30 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[83998268]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83998269]
The customer complained of low results for different assays, some with < test data flags on a cobas 6000 c (501) module. The customer provided erroneous results for 1 patient sample tested for lipc lipase colorimetric assay (lipc). The initial lipc result was 6. 8 u/l with a data flag. This result was reported outside of the laboratory where the physician requested the sample be repeated based on the patient? S history. The sample was repeated and the result was 199. 4 u/l with a data flag. This result was also reported outside of the laboratory. There was no allegation that an adverse event occurred. The lipc reagent lot number and expiration date were not provided. The customer? S liquid level detection and sample probe were checked and replaced. Based on the information available for investigation, an issue with the sample probe has been excluded. Alarms related to abnormal sample aspirations were observed during a review of the alarm trace. The results from the lipc test indicate an issue with sample volume. Taking these observations into consideration, a pre-analytic issue is suspected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01850 |
| MDR Report Key | 6829654 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-30 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-08-10 |
| 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 |
| 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 | 1823260-03/14/17-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHI |
| Date Received | 2017-08-30 |
| 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 | 2017-08-30 |
| 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 | 2017-08-30 |