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 2017-07-07 for COBAS INTEGRA 800 I800 28122474001 manufactured by Roche Diagnostics.
[79525053]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79525054]
The customer complained of erroneous results for 1 patient sample tested for iga immunoglobulin a (iga) on a cobas integra 800. The initial iga result was 180 mg/dl. This result was reported outside of the laboratory. On (b)(6) 2017 the physician questioned the result and the patient sample was repeated on the same instrument and the result was 20 mg/dl. The result of 20 mg/dl was provided to the physician through a corrected result report. The physician stated the result of 20 mg/dl more accurately reflected the patient's condition. The sample was repeated again on (b)(6) "2107" and the result was similar to the result of 20 mg/dl on (b)(6) 2017. The actual result from (b)(6) 2017 was not provided. The customer repeated 10 patient samples tested for iga prior to this patient and 10 patient samples after this patient and the results corresponded to one another. No corrected result reports were necessary. No adverse event occurred. The patient was not treated based on the result of 180 mg/dl. The iga reagent lot number and expiration date were not provided. The field service engineer (fse) visited the customer site and no issues were identified with the instrument. The fse believed the erroneous result was due to a bubble on the sample. The fse performed fluidics and mechanism checks on the instrument and no problems were found. Precision testing was performed on the iga assay and the results were within specification.
Patient Sequence No: 1, Text Type: D, B5
[132620326]
The customer stated there have been no further issues. The customer agrees there could have been a bubble on the sample. The investigation determined that the bubble on the sample found by the fse was the root cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01399 |
| MDR Report Key | 6692293 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-07 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-20 |
| Date Added to Maude | 2017-07-07 |
| 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 | 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 | CFQ |
| Date Received | 2017-07-07 |
| Model Number | I800 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-07 |
| Model Number | I800 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-07 |