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 2016-12-19 for COBAS INTEGRA IGA GEN 2 05219205190 manufactured by Roche Diagnostics.
[62800754]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62800755]
The customer stated that they received an erroneous result for one patient sample tested for iga-2 tina-quant iga gen. 2 (iga) on a cobas 8000 c 702 module (c702). The sample resulted as 24 mg/dl and this value was reported outside of the laboratory. The physician expected a lower iga result due to the clinical condition of the patient. The sample was not retested. The patient has a disease that causes a lack of iga production, but the customer could not provide the specific disease name. The patient was not adversely affected. The serial number of the c702 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[66345279]
The customer later clarified that the patient has an isolated deficiency of iga. The following history of the patient was provided: on (b)(6) 2013 iga result siemens: 3. 0 mg/dl (reference range: 40 to 350 mg/dl), on (b)(6) 2014 iga result siemens: 4. 0 mg/dl (reference range: 40 to 350 mg/dl), on (b)(6) 2015 iga result roche: 15. 0 mg/dl (reference range: 34 to 305 mg/dl). Investigations determined that there is no evidence that something went wrong with the iga measurement. The data provided from the patient's history are old and therefore questionable to link to the current measured data. It should also be considered that expected values for children increases over time. Calibration and control values looked good. The patient value of 24 mg/dl is below expected values for children aged 9 years (34 - 305 mg/dl).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-02006 |
| MDR Report Key | 6187434 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-19 |
| Date of Report | 2017-01-30 |
| Date of Event | 2016-11-25 |
| Date Mfgr Received | 2016-12-07 |
| Date Added to Maude | 2016-12-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2016-12-19 |
| Model Number | NA |
| Catalog Number | 05219205190 |
| Lot Number | 13162801 |
| ID Number | NA |
| Device Expiration Date | 2017-11-30 |
| 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 | 2016-12-19 |