MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-11-28 for COBAS INTEGRA 800 28122474990 manufactured by Roche Diagnostics.
[3000151]
From (b)(6) 2012, the customer received questionable gentamicin results for 18 samples from adults and babies. Of the data provided, only the results for five patient samples were discrepant. Patient sample (b)(6) results were 3. 94, 2. 92, 3. 40 and 2. 99 mg/l. On (b)(6) 2012, patient sample (b)(6) results were 2. 43, 1. 02, 1. 94 and 1. 11 mg/l. On (b)(6) 2012, the results were 0. 64 and 0. 64 mg/l. On (b)(6) 2012, patient sample (b)(6) results were 1. 75, 0. 49, 0. 23, 2. 53, 0. 57, 0. 26, 0. 19 and 0. 20 mg/l. On (b)(6) 2012, patient sample (b)(6) results were 1. 98, 0. 80, 0. 79, 0. 76 and 0. 74 mg/l. On (b)(6) 2012, patient sample (b)(6) results were 1. 56, 1. 09, 2. 50, 0. 86 mg/l. In some cases, the wrong result was reported, in other cases the correct result was reported. No information was provided to determine which results were reported. The patients were not adversely affected. The gentamicin reagent lot number and expiration date were not provided.
Patient Sequence No: 1, Text Type: D, B5
[10339066]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[18521297]
On (b)(6) 2013, additional results were provided for six patient samples. Of the data provided, the results for two samples were discrepant. On (b)(6) 2012, patient sample 1 results were 4. 28, 2. 76, 2. 67, 3. 68, 2. 85 and 2. 52 mg/l. The result of 2. 52 mg/l was reported outside the laboratory. On (b)(6) 2012, patient sample 2 results were 1. 91, 0. 52, 0. 58 and 0. 43 mg/l. The results of 0. 58 and 0. 43 mg/l were reported outside the laboratory. No information was provided to determine if the patients were adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[18523615]
The investigation could not determine a specific root cause as the field service representative performed multiple actions. The issue was probably caused by a worn out o-ring and/or motor of the fp photometer polarization filter. The field service representative replaced these parts as well as the lamp led of the fp photometer and then performed a new fp calibration. No adverse event was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-06028 |
| MDR Report Key | 2849500 |
| Report Source | 01,05,06 |
| Date Received | 2012-11-28 |
| Date of Report | 2013-04-17 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2012-11-14 |
| Date Added to Maude | 2012-11-28 |
| 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 | LCD |
| Date Received | 2012-11-28 |
| Model Number | NA |
| Catalog Number | 28122474990 |
| 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 | 2012-11-28 |