MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-24 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[98069233]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[98069234]
The customer stated that from approximately (b)(6) 2017 to (b)(6) 2018, they have seen a shift in quality control and patient results for ise indirect k for gen. 2 (potassium) on the cobas 6000 c (501) module - c501. Sodium and chloride ise tests were fine. On (b)(6) 2017, a doctor questioned high potassium results for an unspecified number of patient samples. The customer pulled these samples and repeated them. Repeat results for these samples were lower than the initial results. The customer then repeated all samples that were tested that day and corrected reports for multiple patient samples. Results from the customer site were also consistently high compared to results obtained at a sister facility. The customer provided data for a total of 9 patient samples that had erroneous initial results which were reported outside of the laboratory. The repeat results from these samples were believed to be correct. The first sample initially resulted as 5. 32 mmol/l and repeated as 4. 58 mmol/l. The second sample initially resulted as 5. 6 mmol/l and repeated as 4. 8 mmol/l. The third sample initially resulted as 5. 2 mmol/l and repeated as 4. 5 mmol/l. The fourth sample initially resulted as 4. 6 mmol/l and repeated as 3. 9 mmol/l. The fifth sample initially resulted as 4. 7 mmol/l and repeated as 4. 1 mmol/l. The sixth sample initially resulted as 4. 9 mmol/l and repeated as 4. 2 mmol/l. The seventh sample initially resulted as 5. 0 mmol/l and repeated as 4. 4 mmol/l. The eighth sample initially resulted as 5. 1 mmol/l and repeated as 4. 5 mmol/l. The ninth sample initially resulted as 5. 1 mmol/l and repeated as 4. 4 mmol/l. No patients were treated based on the erroneous results. No patients were adversely affected. The lot number and expiration date of the potassium electrode was asked for, but not provided. The customer checked the instrument and did not find anything obviously wrong, except that it seemed like there was a larger amount of salt buildup on the ise concentrated waste nipple. The customer started running controls every two hours and started monitoring their results using delta checks. The field service engineer found that there was salt buildup on the reference electrode. He performed cleaning of the ise chamber. He performed a successful ise check, quality controls, and precision studies.
Patient Sequence No: 1, Text Type: D, B5
[132931197]
The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00207 |
| MDR Report Key | 7215020 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-24 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-03 |
| Date Mfgr Received | 2018-01-10 |
| Date Added to Maude | 2018-01-24 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | CEM |
| Date Received | 2018-01-24 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-01-24 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 | 2018-01-24 |