MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-30 for COBAS INTEGRA 800 28122474692 manufactured by Roche Diagnostics.
[17448949]
The customer received a questionable hemoglobin a1c result for one patient sample. The initial result was 3. 92% and was reported outside the laboratory. The physician called and questioned the result as the patient is a known diabetic. The customer pulled the sample and repeated testing with results of 7. 94% and 7. 83%. The repeat result was believed to be correct and the physician was notified of the corrected result. The customer was not aware of any adverse impact to the patient as the physician questioned the original result and did not modify treatment for the patient. The hemoglobin a1c reagent lot number was 68602501 with an expiration date of 09/30/2014. The field service representative determined the issue was possibly caused by a defective st2 probe air dryer. He found the st2 probe wash station was covered in dried blood. He replaced both sample probe air dryers, all six syringes and both sample probes. He cleaned dried blood from the sample wash stations and from multiple places within the analyzer section. The customer ran qc samples without issue.
Patient Sequence No: 1, Text Type: D, B5
[17776141]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06687 |
| MDR Report Key | 3437953 |
| Report Source | 05,06 |
| Date Received | 2013-10-30 |
| Date of Report | 2013-10-30 |
| Date of Event | 2013-10-22 |
| Date Mfgr Received | 2013-10-23 |
| Date Added to Maude | 2013-10-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2013-10-30 |
| Model Number | NA |
| Catalog Number | 28122474692 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-30 |