MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-27 for COBAS INTEGRA 800 28122474001 manufactured by Roche Diagnostics.
[11727238]
The investigation could not determine a specific root cause. It was noted that pre-analytical factors were most likely, but this could not be confirmed as additional information for further investigation was requested but not provided. On further follow up, the customer indicated they have not had a further issue with results since service was in and fixed the instrument.
Patient Sequence No: 1, Text Type: N, H10
[21450967]
The customer received questionable results for tina-quant hemoglobin a1c gen. 2 (hba1c) on one patient sample. The customer indicated that while they reviewed the test result data from (b)(6) 2014 they noted they had other samples that they noticed were accompanied by data flags. To the customer's knowledge, no other results without a data flag were erroneous. On (b)(6) 2014, the initial hba1c result of 8. 58%, which was reported outside of the laboratory as 8. 6%. The result was questioned by the physician. The same sample tube was repeated on the same instrument on (b)(6) 2014, and generated a repeat result of 5. 40%. The sample was repeated again on the same instrument and generated a result of 5. 3%. The sample was also repeated on another integra 800 instrument and generated a result of 5. 3%. The customer deemed the repeat result to be correct. There was no adverse event. As part of troubleshooting, the customer repeated the sample and continued to get data errors when hba1c was run. The customer indicated that they are still receiving the data errors and cannot confirm if any of the results involved are errant. No further information was provided by the customer. The lot number of the hba1c reagent in use was 68050701, with an expiration date of 05/31/2014. The field service representative found a fluidic failure of a sample probe. He replaced the sample probe and syringes. He performed a check test, the results of which were within specification. On further follow up, the customer noted that qc was completed after the service visit and "it looks good".
Patient Sequence No: 1, Text Type: D, B5
[21666451]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-02137 |
| MDR Report Key | 3704229 |
| Report Source | 05,06 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2014-03-11 |
| Date Added to Maude | 2014-03-27 |
| 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 MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 | 2014-03-27 |
| Model Number | NA |
| Catalog Number | 28122474001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-27 |