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 2016-09-19 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[55102484]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[55102485]
The customer complained of erroneous results for 1 patient sample tested for aslot tina-quant antistreptolysin o (aslot). The erroneous results were between 2 c 501 analyzers. It is not known if erroneous results were reported outside of the laboratory. It is not known which results were considered to be correct. This medwatch will cover c 501 analyzer with serial number (b)(4). The initial aslot result from c 501 analyzer with serial number (b)(4) at 9:20 a. M. Was >600 iu/ml. The instrument performed an auto dilution resulting in 2088 iu/ml. The sample was repeated on c 501 analyzer with serial number (b)(4) and the result was 581 iu/ml. This result was reported to the patient. The sample was repeated again on c 501 analyzer with serial number (b)(4) at 10:50 a. M. And the result was 2053 iu/ml. It is not clear if this result was performed with dilution by the instrument automatically or by the customer manually. No adverse event occurred. The aslot reagent lot number is 125020. The expiration date was not provided. The same reagent lot is being used on both analyzers. The investigation noted that the measuring range for aslot is 20-600 iu/ml and the expected value for adults is up to 200 iu/ml. The investigation also noted that the difference in results between the 2 analyzers may be due to different unknown issues of each analyzer. It was suggested that the result of 581 iu/ml from the c501 analyzer with serial number (b)(4) could have been caused by an insufficient amount of sample being pipetted.
Patient Sequence No: 1, Text Type: D, B5
[57584367]
It was clarified that the repeat result of 2053 iu/ml on c 501 analyzer with serial number (b)(4) at 10:50 a. M. Was a dilution result performed by the instrument. An additional repeat result of 552 iu/ml was provided that was rerun after the result of 581 iu/ml on c 501 analyzer with serial number (b)(4). Both of these results were performed by instrument dilution.
Patient Sequence No: 1, Text Type: N, H10
[58962639]
Based on a review of the alarm traces for both analyzers, no issues were identified. Based on the information available for investigation, a specific root cause could not be identified. Additional information was requested for investigation but was not provided. The customer stated they have been doing manual dilutions in parallel to the instrument dilutions to check performance. All results have corresponded. The customer has stopped the parallel testing and believes this is a single sample related incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01407 |
| MDR Report Key | 5960376 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-19 |
| Date of Report | 2016-11-01 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2016-08-31 |
| Date Added to Maude | 2016-09-19 |
| 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 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | GTQ |
| Date Received | 2016-09-19 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-09-19 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 | 2016-09-19 |