MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-20 for COBAS INTEGRA 800 28122474001 manufactured by Roche Diagnostics.
[2496190]
The customer received questionable calcium results on their integra 800 analyzer. The customer provided data for five patients with discrepant results reported outside the laboratory. The customer repeated the samples on another integra 800, serial number (b)(4). The customer then repeated the samples on the first integra 800 analyzer using a new calcium cassette. The first repeat results were issued as corrected reports. The first patient's initial calcium result was 13. 0 mg/dl. The first repeat result was 7. 0 mg/dl. The second repeat result was 7. 3 mg/dl. The second patient's initial calcium result was 13. 3 mg/dl. The first repeat result was 9. 6 mg/dl. The second repeat result was 9. 8 mg/dl. The third patient's initial calcium result was 12. 0 mg/dl. The first repeat result was 9. 5 mg/dl. The second repeat result was 10. 6 mg/dl. The fourth patient's initial calcium result was 12. 1 mg/dl. The first repeat result was 9. 5 mg/dl. The second repeat result was 9. 9 mg/dl. The fifth patient's initial calcium result was 12. 8 mg/dl. The first repeat result was 8. 3 mg/dl. The second repeat result was 9. 0 mg/dl. There were no adverse events. The calcium reagent lot number was 64932001 and the expiration date was 03/31/2012. The field service representative found loose fittings on the reagent probe. He tightened all the probes. The analyzer was running to specification. The customer performed calibration and quality control. The customer was satisfied with the quality control results.
Patient Sequence No: 1, Text Type: D, B5
[9558635]
.
Patient Sequence No: 1, Text Type: N, H10
[20970140]
A specific root cause could not be determined. Since the quality control was measured within range, the loose fittings on the probes were not the cause. It is more probable that the high initial calcium results were due to pre-analytic issues or lack of maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-06835 |
| MDR Report Key | 2382848 |
| Report Source | 05,06 |
| Date Received | 2011-12-20 |
| Date of Report | 2012-04-09 |
| Date of Event | 2011-12-09 |
| Date Mfgr Received | 2011-12-10 |
| Date Added to Maude | 2011-12-20 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | CH |
| 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 | JFP |
| Date Received | 2011-12-20 |
| Model Number | NA |
| Catalog Number | 28122474001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-12-20 |