MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for ASLOT TINA-QUANT ANTISTREPTOLYSIN O 05219191190 manufactured by Roche Diagnostics.
[71720697]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71720698]
The customer stated that they have been getting erroneously high results for 5 samples from the same patient tested with multiple lot numbers of aslot tina-quant antistreptolysin o (aslo) on a cobas 8000 c 702 module (c702). The results from the patient have been persistently high and this does not fit the clinical picture of the patient. The first sample, tested on (b)(6) 2016, resulted as 785 ku/l. The second sample, tested on (b)(6) 2016, resulted as 2289. 7 ku/l. The third sample, tested on (b)(6) 2017, resulted as 2504. 0 ku/l. The fourth sample, tested on (b)(6) 2017, resulted as 2708. 4 ku/l. The fifth sample, tested on (b)(6) 2017, resulted as 2414. 5 ku/l. This sample was diluted times five and resulted as 508. 5 x5 = 2542. 5 ku/l. This sample was diluted times ten and resulted as 261. 0 x 10 = 2610 ku/l. This sample was also diluted times twenty and resulted as 100. 1 x 20 = 2002 ku/l. The customer states that the aslo titer continues to rise, but they do not think the patient has an immune-mediated post-streptococcal complication. The customer states that if the patient did indeed have a streptococcal infection at the onset, then the titers should be settling. The customer suspects there is an interferent in the patient samples which interferes with the aslo assay. There were no allegations of an adverse event with the patient. The serial number of the used c702 analyzer was requested, but not provided. Sample tests were performed using aslo reagent lot numbers 144217, 196228, and 131178.
Patient Sequence No: 1, Text Type: D, B5
[73575732]
The customer was having issues with the analyzer vacuum pump, so this was exchanged. Precision studies were performed before and after the pump exchange. The customer also noted that they have had poor performance for proficiency samples tested for (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77954138]
The customer performed an additional dilution study with a sixth sample from the same patient on (b)(6) 2017. All dilutions were performed using saline as the diluent. The following also values were obtained for the sample: 2519. 9 ku/l when run without dilution. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120146524]
The presence of an interferent in the patient sample can be excluded based on the dilution experiments. The results of the diluted sample confirmed the result of the undiluted sample. No product problem was found.
Patient Sequence No: 1, Text Type: N, H10
[132589522]
Medwatch has been updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00695 |
| MDR Report Key | 6452959 |
| Date Received | 2017-04-03 |
| Date of Report | 2018-08-20 |
| Date of Event | 2016-04-19 |
| Date Mfgr Received | 2017-03-14 |
| Date Added to Maude | 2017-04-03 |
| 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 | ASLOT TINA-QUANT ANTISTREPTOLYSIN O |
| Generic Name | ANTISTREPTOLYSIN - STREPTOLYSIN O REAGENT |
| Product Code | GTQ |
| Date Received | 2017-04-03 |
| Model Number | NA |
| Catalog Number | 05219191190 |
| Lot Number | 131178 |
| 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 | 2017-04-03 |