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 2017-04-17 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[72879322]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
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The customer initially stated that electrodes and tubing were replaced by the field service engineer on 03/10/2017 as part of preventive maintenance for the cobas 6000 c (501) module - c501 analyzer. The customer stated that erroneous initial results were reported outside of the laboratory for 8 patient samples tested for ise indirect ci for gen. 2 (chloride) on (b)(6) 2017. These samples were repeated on the same analyzer and the repeat results were believed to be correct. Refer to the attachment for all patient data. The patients were not adversely affected. The chloride electrode lot number and expiration date were asked for, but not provided. On (b)(6) 2017, the customer stated that they were having calibration issues with the ise tests on the c501 analyzer on (b)(6) 2017. The customer calibrated the analyzer since multiple patient samples were showing decreased anion gap results. The customer replaced the potassium chloride system reagent and re-calibrated. Calibrations looked better. Controls and patient results were testing well. The customer has a low throughput of testing on the analyzer. Internal standard and diluent system reagents had been on board the analyzer for a while and were getting low. The customer also stated that the humidity in their laboratory was low. The customer was advised that humidity outside of analyzer specifications can cause evaporation of system reagents. The customer was advised to replace the system reagent bottles, perform a prime, run an ise check 30 times, and then recalibrate. The customer stated that controls were drifting on (b)(6) 2017 and this was resolved by replacing the system reagents and re-calibrating. The customer declined a service visit. A specific root cause could not be determined based on the provided information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00790 |
| MDR Report Key | 6496811 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-17 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-03-28 |
| Date Added to Maude | 2017-04-17 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CGZ |
| Date Received | 2017-04-17 |
| 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 | 2017-04-17 |
| 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 | 2017-04-17 |