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 2017-10-27 for COBAS INTEGRA 400 PLUS I400+ 03245233990 manufactured by Roche Diagnostics.
[90951491]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90951492]
The customer complained of an erroneous high result for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas integra 400 plus. The initial gluc3 result was 193. 37 mg/dl. This result was reported outside of the laboratory. The patient requested that the sample be repeated. The customer repeated the sample twice with results of 103. 88 mg/dl and 103. 93 mg/dl. There was no allegation that an adverse event occurred. The gluc3 reagent lot number was 23629001 with an expiration date of 31-jul-2017. On (b)(6) 2017 the customer also had issues with high ldl results; however these results were not discrepant. Calibration and quality controls (qc) were acceptable. During a review of the alarm trace, frequent "no fluid/not enough" alarms occurred. Based on this alarm, it is possible that the sample probe transferred an incorrect amount of sample volume causing a higher level. It is possible the tube settings do not match the filling volume which can cause the sample probe to go too far into the sample. Product labeling states only one type of sample tube or cup can be used in each rack. Different tube types must not be mixed on the same rack. The customer has checked their rack settings and they seem to be correct. The customer uses a clotting time of 20 minutes which was most likely too short. Based on the information available, a general reagent problem can be ruled out since calibration and qc were acceptable
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02432 |
| MDR Report Key | 6982796 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-27 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-10-07 |
| Date Mfgr Received | 2017-10-07 |
| Date Added to Maude | 2017-10-27 |
| 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 | 0 |
| 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 INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFR |
| Date Received | 2017-10-27 |
| Model Number | I400+ |
| Catalog Number | 03245233990 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-27 |