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 2017-03-14 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[69902000]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69902001]
The customer received analyzer alarms and questionable low results for patient samples. Of the data provided for two patient samples, only the erroneous result for one sample was reported outside the laboratory. The hdlc3 hdl-cholesterol plus 3rd generation result was 3mg/dl with a data flag. This result was reported outside the laboratory. The repeat result on (b)(6) 2017 from the same tube and from another tube from the same venipuncture was 48 mg/dl. This result was believed to be correct. The patient was not adversely affected. The reagent lot number was 14048201 with an expiration date of 01/31/2018. The field service representative found the sample probe mechanism was misaligned in various positions. He performed mechanical and electrical alignments of the sample probe mechanism. He performed mechanical, electrical, and fluidic checks of the instrument without errors. The customer was able to run qc and patient samples. He found the instrument was performing to specifications. A specific root cause could not be determined. A likely root cause was the preanalytic handling of the sample. Based on the provided analyzer alarm information, on the date of the event there was no analyzer alarm near the time the sample was being pipetted. Therefore the issue found by the field service representative should not have affected this sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00556 |
| MDR Report Key | 6403539 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-14 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2017-02-27 |
| Date Added to Maude | 2017-03-14 |
| 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 | LBS |
| Date Received | 2017-03-14 |
| 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 | 2017-03-14 |
| 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 | 2017-03-14 |