MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-06-23 for COBAS INTEGRA IGA GEN 2 03507343190 manufactured by Roche Diagnostics.
[48058236]
This event occurred in (b)(6). Facility name - the full facility name was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[48058237]
The customer stated that they received an erroneous result for one patient sample tested for tina-quant iga gen. 2 (iga) on a c502 analyzer. The sample initially resulted as <0. 5 g/l. The sample was repeated with an increased sample volume, resulting as <0. 05 g/l which was reported outside of the laboratory. The sample was sent to another laboratory, where it was tested on a different analyzer, resulting as 0. 32 g/l. The patient was not adversely affected. The c502 analyzer serial number was asked for, but not provided. It was noted that the customer was using a standard iga test application, instead of the sensitive application of the test.
Patient Sequence No: 1, Text Type: D, B5
[49062672]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. Calibration and quality controls were within range. It was noted the customer was using the standard iga application with a measuring range of 0. 50-8. 00 g/l instead of the sensitive iga application which has a measuring range of 0. 1-4. 0 g/l. It was suggested to the customer to use the sensitive application for these types of samples.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00802 |
| MDR Report Key | 5745359 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-23 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-03 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-06-23 |
| 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 | 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 DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA IGA GEN 2 |
| Generic Name | IMMUNOGLOBULIN A |
| Product Code | CZP |
| Date Received | 2016-06-23 |
| Model Number | NA |
| Catalog Number | 03507343190 |
| Lot Number | ASKU |
| 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 | 2016-06-23 |