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 2017-01-25 for IGM-2 TINA-QUANT IGM GEN.2 manufactured by Roche Diagnostics.
[65710382]
This event occurred in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[65710383]
The customer stated that they received erroneous results for one patient sample tested for igm-2 tina-quant igm gen. 2 (igm) on a cobas 6000 c (501) module - c501. The customer stated that results were higher when running the sample without dilution and with automatic dilution versus results obtained with a dilution directly ordered on the analyzer. An erroneous result may have been reported outside of the laboratory. The sample initially resulted as 41. 86 g/l accompanied by a data flag. The sample was repeated with a reduced sample volume, resulting as 58. 70 g/l accompanied by a data flag. The sample was repeated a second time without dilution, resulting as 30. 18 g/l accompanied by a data flag. The sample was repeated a third time with a 1:2 dilution ordered on the analyzer, resulting with a raw value of 27. 74 g/l. The printout of the result indicated that it was run with reduced sample volume. When multiplied by a dilution factor of 2, the final result was 55. 48 g/l. The sample was repeated a fourth time without dilution, resulting as 41. 86 g/l accompanied by a data flag. The sample was repeated a fifth time with a 1:5 dilution ordered on the analyzer, resulting as 0. 50 g/l. This value was reported outside of the laboratory. The sample was repeated a sixth time on (b)(6) 2017 with a 1:5 manual dilution, resulting with a raw value of 12. 04 g/l accompanied by a data flag. The sample was repeated a seventh time on (b)(6) 2017 with a 1:5 manual dilution, resulting with a raw value of 10. 80 g/l. The printout of the result indicated that it was run with reduced sample volume. When multiplied by a dilution factor of 5, the final result was 54 g/l. The sample was repeated an eighth time on (b)(6) 2016 with a 1:5 dilution ordered on the analyzer, resulting with a raw value of 0. 46 g/l. The patient was not adversely affected. The serial number of the c501 analyzer was (b)(4). The igm application requires a pre-dilution of 1:21. This dilution is programmed in the application. When the user programs a dilution of the sample directly on the analyzer, this dilution overrides the required 1:21 pre-dilution. For example, when the user programmed a 1:5 dilution on the analyzer, the analyzer made a 1:5 dilution of the sample, but did not make the required 1:21 dilution, resulting in the analyzer testing a sample that was approximately 4 times too concentrated for this application. This issue is covered in product labeling. The result obtained in this case may be subject to a high dose hook effect. The result of 0. 5 g/l may therefore be incorrect. By ordering a dilution directly on the system the customer disabled the required pre-dilution step. When the customer made a manual dilution before placing the sample on the analyzer, the analyzer made the required 1:21 pre-dilution in addition to the manual dilution made by the customer. The result of 54 g/l may be correct, but this could not be determined based on the available information. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[67569316]
With regards to the following statements in the initial medwatch : "the sample was repeated a sixth time on (b)(6) 2017 with a 1:5 manual dilution, resulting with a raw value of 12. 04 g/l accompanied by a data flag. The sample was repeated a seventh time on (b)(6) 2017 with a 1:5 manual dilution, resulting with a raw value of 10. 80 g/l. The printout of the result indicated that it was run with reduced sample volume. When multiplied by a dilution factor of 5, the final result was 54 g/l. " it was clarified that the sample was manually diluted with nacl to obtain the result of 12. 04 g/l accompanied by a data flag. The sample was then automatically repeated at a reduced sample volume to obtain the repeat value of 10. 80 g/l. The operator's manual describes the process of ordering dilutions and informs users that selecting a dilution on the analyzer will overwrite the pre-programmed dilution for the test.
Patient Sequence No: 1, Text Type: N, H10
[68620430]
Medwatch field d4 lot number has been updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00138 |
| MDR Report Key | 6276012 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-25 |
| Date of Report | 2017-02-24 |
| Date of Event | 2016-12-29 |
| Date Mfgr Received | 2017-01-04 |
| Date Added to Maude | 2017-01-25 |
| 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 | IGM-2 TINA-QUANT IGM GEN.2 |
| Generic Name | IGM (MU CHAIN SPECIFIC) |
| Product Code | DAO |
| Date Received | 2017-01-25 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 172445 |
| 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 | 2017-01-25 |