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 2017-05-12 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[75029361]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75029362]
The customer questioned results for 2 patient samples tested for li lithium (li) on a cobas 6000 c (501) module. Based on the data provided, the results for 1 patient were erroneous and reported outside of the laboratory. The initial li result was 2. 76 mmol/l. This result was reported outside of the laboratory where it was questioned by the doctor since previous li results from this patient had been low. On (b)(6) 2017 the sample was repeated and the result was 0. 35 mmol/l. This result was believed to be correct. No adverse event occurred. The li reagent lot number was 166829 with an expiration date of 05/31/2018. The reagent was loaded and calibrated on (b)(6) 2017. Instrument maintenance was up to date.
Patient Sequence No: 1, Text Type: D, B5
[76532904]
The patient's sample was slightly turbid and had minute blood clots floating in it. The field service engineer (fse) visited the customer site. He performed instrument checks. The fse noted that there was no nozzle seal on the sample probe. The probe was flushed several times with distilled water to remove residue. The sample probe was re-installed with a new nozzle seal. The customer ran quality controls and the results were acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00989 |
| MDR Report Key | 6562775 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-12 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-04-11 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-12 |
| 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 | NDW |
| Date Received | 2017-05-12 |
| 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 | 2017-05-12 |
| 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 | 2017-05-12 |