MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-13 for TRIGLYCERIDES, GPO-PAP 11730711216 manufactured by Roche Diagnostics.
[3405628]
The customer received questionable results for triglycerides gpo-pap (trig) on a total of 24 patients. The customer began to see patient results running high around 1:00 pm on (b)(6) 2013; 15 patient samples were moved to another hitachi modular p (modp) analyzer serial number (b)(4). The results from modp serial number (b)(4) were reported. The customer did not provide data for these 15 samples. On (b)(6) 2013, the customer repeated 9 patients on modp serial number (b)(4). Of these 9 patients, 7 were determined to have erroneous results that were reported outside of the laboratory. All results are in mg/dl. Patient (b)(6) had an original trig result of 296. The sample was repeated on modp serial number (b)(4) and generated a result of 135. The customer had changed reagents on the original analyzer and repeated the sample again. The repeat result on the original analyzer was 133. Patient (b)(6) had an original trig result of 227. The sample was repeated on modp serial number (b)(4) and generated a result of 135. The customer had changed reagents on the original analyzer and repeated the sample again. The repeat result on the original analyzer was 135. Patient (b)(6) had an original trig result of 403. The sample was repeated on modp serial number (b)(4) and generated a result of 140. The customer had changed reagents on the original analyzer and repeated the sample again. The repeat result on the original analyzer was 137. Patient (b)(6) had an original trig result of 444. The sample was repeated on modp serial number (b)(4) and generated a result of 177, accompanied by a data flag. The customer had changed reagents on the original analyzer and repeated the sample again. The repeat result on the original analyzer was 173, accompanied by a data flag. Patient (b)(6) had an original trig result of 409. The sample was repeated on modp serial number (b)(4) and generated a result of 157, accompanied by a data flag. The customer had changed reagents on the original analyzer and repeated the sample again. The repeat result on the original analyzer was 157, accompanied by a data flag. Patient (b)(6) had an original trig result of 352. The sample was repeated on modp serial number (b)(4) and generated a result of 85. The customer had changed reagents on the original analyzer and repeated the sample again. The repeat result on the original analyzer was 81. Patient (b)(6) had an original trig result of 403. The sample was repeated on modp serial number (b)(4) and generated a result of 107. The customer had changed reagents on the original analyzer and repeated the sample again. The repeat result on the original analyzer was 106. The customer deemed the repeat results from modp serial number (b)(4) to be the correct results. There was no adverse event. The serial number of the modp analyzer in question is (b)(4). The field service representative found that there might have been a possible issue with the medium reagent bottles. The customer changed to large reagent bottles. He observed the instrument on (b)(6) 2013 and it was rinsing and stirring ok.
Patient Sequence No: 1, Text Type: D, B5
[10750130]
The investigation could not determine a specific root cause. It was noted that contamination of the reagent could be a possible root cause.
Patient Sequence No: 1, Text Type: N, H10
[10770277]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[18761949]
The fsr stated there were no signs of reagent dripping. There were no signs of liquid level detection problems. No other tests were having issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-02901 |
| MDR Report Key | 3109536 |
| Report Source | 05,06 |
| Date Received | 2013-05-13 |
| Date of Report | 2013-06-24 |
| Date of Event | 2013-04-17 |
| Date Mfgr Received | 2013-04-18 |
| Date Added to Maude | 2013-05-13 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | TRIGLYCERIDES, GPO-PAP |
| Generic Name | LIPASE HYDROLYSIS/GLYCEROL KINEASE ENZYME, TRIGLYCERIDES |
| Product Code | CDT |
| Date Received | 2013-05-13 |
| Model Number | NA |
| Catalog Number | 11730711216 |
| Lot Number | 67008301 |
| ID Number | NA |
| Device Expiration Date | 2013-09-30 |
| 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 | 2013-05-13 |