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 2017-08-29 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[86285247]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86285248]
The customer received questionable results for three different tests between the dates of (b)(6) 2017 and (b)(6) 2017. Of the data provided, only the result for alp2 alkaline phosphatase acc. To ifcc gen. 2 was a reportable malfunction. The initial alkaline phosphatase result was 217 u/l. The repeat result was 385 u/l. The sample was repeated due to the gel electrophoresis alkaline phosphatase test showing a result appearing higher than the 217 u/l reported out by the analyzer. The repeat result is believed to be correct. The initial result was not reported outside the laboratory. There was no adverse event. The sample in question was collected at an off-site facility. The off-site facility pours over the serum from the original collection tube into a false bottom tube where it is frozen and sent to the customer. The customer then thaws the sample, mixes it, and then manually runs it on the analyzer. The initial result for alkaline phosphate was from the original thawed sample run on (b)(6) 2017. The repeat result was from the original sample poured over into a hitachi cup run on (b)(6) 2017. The alp2 alkaline phosphatase acc. To ifcc gen. 2 reagent lot is 19859701 with an expiration date of 8/31/2017. The field engineering specialist found that the sample syringe seal had failed. He replaced the sample syringe seal. He also cleaned the sample probe, the reagent probes, and the incubation bath. The analyzer was then recalibrated along with qc run all of which passed. A pooled serum sample was also run for precision testing which also passed. Further investigation showed that there have been no similar events on any like instruments at this site in the past 12 months. There are no abnormal trends identified in the past 90 days concerning the failing part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01837 |
| MDR Report Key | 6826835 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-08-04 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-08-29 |
| 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 | CJO |
| Date Received | 2017-08-29 |
| 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 | 2017-08-29 |
| 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 | 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 | 2017-08-29 |