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 2015-09-29 for COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY 06600263190 manufactured by Roche Diagnostics.
[27066934]
This event occurred in (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[27066935]
The customer reported that they received an erroneous result for one patient sample tested for tina-quant cystatin c gen. 2 (cystatin c) on a cobas 8000 analyzer. The actual date of the event was asked for, but could not be provided. It is only known that the event may have occurred some time in (b)(6) 2015. The patient has refractory cytopenia and is under conditioning for bone marrow transplantation with antithymozyten-ak (atg) and steroids. The patient also has some fever. The patient had a cystatin c result of 9. 08 mg/l and this value was reported to the physician. The physician did not believe the cystatin c value because the patient was in physically good condition and had a normal creatinine value of 23 umol/l. The physician only considered the creatinine value when treating the patient. The cystatin c of the patient was also measured with a scantibodies tube, with absorption of igm and igg. It was stated that other patients receiving atg therapy had normal cystatin c values and that these values fit in with the creatinine values. It was also believed that steroids should lower cystatin c. The patient was not adversely affected. The cobas 8000 analyzer serial number used for testing was asked for, but not provided. It was stated that the customer has observed this phenomenon with two additional patients. No additional data has been provided with reference to these patients. Additional result data was also provided, but it is not clear what tests are represented, how many samples or patients are involved, or when some of the tests had been performed. Clarifications have been requested.
Patient Sequence No: 1, Text Type: D, B5
[28313377]
The customer provided additional information stating that no other protein was detectable in the patient. The patient had been given an immunoglobulin solution, privigen. Samples at the customer site were spiked with privigen for investigation, and cystatin c was measured in these samples without issue. From the customer's point of view, they believe the result issue is caused by cystatin biology and not the analysis of the sample. The customer noted that literature describes the complained issue in patients with leukemia based on the presence of cathepsin. The customer tested a sample from the patient for cathepsin and excluded an interference of cathepsin. During investigations, it was noted that literature confirms the hypothesis of analytical correctness of the patient sample, although the normal renal function does not reflect such a value for cystatin c. Investigations of the affected patient sample revealed that no antibodies against rabbit antibodies were detected. Medwatch field d11 has been updated.
Patient Sequence No: 1, Text Type: N, H10
[28352855]
The customer has provided additional data for the affected patient. Refer to the attachment. On the attachment, this patient is designated as "patient 1". There are seven total result reports from this patient and each set of measurements were performed from a different sample collected at different times from the patient. The run date for each result can be seen by the date/time indicated next to the word "laboreingang" in the upper right corner of each page. The customer also provided result data for two additional patients where the same phenomenon is seen. These 2 additional patients are designated as "patient 2" and "patient 3. " the cystatin c results from these patients was high in comparison to normal creatinine values. The cystatin c values for these patients were reported to physicians, but the physicians did not believe the values. No additional information could be provided for these patients. Patients 2 and 3 were not adversely affected due to the event.
Patient Sequence No: 1, Text Type: N, H10
[31139777]
A sample from patient 1 was provided for investigation. Based on investigations of the sample, the findings of the customer could be confirmed for this patient. The patient sample was also analyzed for cystatin c using a method from siemens. Based on the siemens result, the result from the roche cystatin c assay could not be confirmed. It is assumed that there is an unknown substance in the sample which interferes with the roche cystatin c assay. Interference by immunoglobulins could be ruled out. A specific root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04247 |
| MDR Report Key | 5110988 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-29 |
| Date of Report | 2015-10-23 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-20 |
| Date Added to Maude | 2015-09-29 |
| 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 C TINA-QUANT CYSTATIN C GEN.2 ASSAY |
| Generic Name | TEST, CYSTATIN C |
| Product Code | NDY |
| Date Received | 2015-09-29 |
| Model Number | NA |
| Catalog Number | 06600263190 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-29 |